NDC properties for "ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution" (RxCUI 240984)
About this data
The tables show NDC propoerties for ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution with the RxCUI 240984
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product
Details for ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution (RxCUI 240984)
| ANDA | ANDA065188 |
|---|---|
| ANDA | ANDA065314 |
| ANDA | ANDA065403 |
| ANDA | ANDA090339 |
| ANDA | ANDA090578 |
| MMSL_CODE | BD1347 |
| MMSL_CODE | CD1347 |
| RxCUI | 240984 |
| SPL_SET_ID | 139b4b2e-46f7-44a8-9cc1-774afa463b80 |
| SPL_SET_ID | 2709e9fc-2341-4382-af72-c2e3201bd77a |
| SPL_SET_ID | 2bfc6187-c9fc-4115-92d6-53910b5960da |
| SPL_SET_ID | 35606b43-5914-423c-9bc7-fa3957eb2563 |
| SPL_SET_ID | 437a26f4-776b-4f74-99b2-09ad79831b0c |
| SPL_SET_ID | 577dd6f0-d56a-4c82-9f72-274c3a4a0f01 |
| SPL_SET_ID | 5e8d35cb-e93d-42ad-a02c-0dbf04910f61 |
| SPL_SET_ID | 77158167-0c1e-4f01-a5b0-a3df8ad121f5 |
| SPL_SET_ID | 9f2ff165-2a21-4155-a4f0-57885a83c7dc |
| SPL_SET_ID | a65a70bf-4283-4bc0-b576-00c9ab29bd64 |
| VUID | 4008600 |
| Prescribable Synonym | ampicillin 100 MG / sulbactam 50 MG per ML Injectable Solution |
| RXNAV_STR | ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution |
| RxNorm Name | ampicillin 100 MG/ML / sulbactam 50 MG/ML Injectable Solution |
| RxNorm Synonym | ampicillin (as ampicillin sodium) 10 GM / sulbactam (as sulbactam sodium) 5 GM per 100 ML Injectable Solution |
| RxNorm Synonym | ampicillin (as ampicillin sodium) 100 MG/ML / sulbactam (as sulbactam sodium) 50 MG/ML Injectable Solution |
| Related queries | Interactions (for RxCUI 240984) |
NDC Properties
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |
NDC Item 00641611801
| NDC 9 | 0641-6118 |
|---|---|
| NDC 10 | 0641-6118-01 |
| NDC Item | 00641611801 |
| Packaging | 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (0641-6118-01) |
| ANDA | ANDA065403 |
| FDA SPL set id | 802596 |
| Labeler | Hikma Pharmaceuticals USA Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2009-12-03 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 0641-6118 |
NDC Item 00781303446
| NDC 9 | 0781-3034 |
|---|---|
| NDC 10 | 0781-3034-46 |
| NDC Item | 00781303446 |
| Packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, PHARMACY BULK PACKAGE (0781-3034-46) |
| ANDA | ANDA065241 |
| FDA SPL set id | 526354 |
| Labeler | Sandoz Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-07-25 |
| Marketing status | DROPPED |
| Related queries | Properties for NDC 9 0781-3034 |
NDC Item 25021014499
| NDC 9 | 25021-144 |
|---|---|
| NDC 10 | 25021-144-99 |
| NDC Item | 25021014499 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-144-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA065403 |
| FDA SPL set id | 833254 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2010-08-12 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 25021-144 |
NDC Item 25021018899
| NDC 9 | 25021-188 |
|---|---|
| NDC 10 | 25021-188-99 |
| NDC Item | 25021018899 |
| Packaging | 1 BOTTLE in 1 CARTON (25021-188-99) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 549274 |
| Labeler | Sagent Pharmaceuticals |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2021-03-31 |
| Marketing effective time low | 2017-08-15 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 25021-188 |
NDC Item 44567021201
| NDC 9 | 44567-212 |
|---|---|
| NDC 10 | 44567-212-01 |
| NDC Item | 44567021201 |
| Packaging | 1 VIAL in 1 CARTON (44567-212-01) / 100 mL in 1 VIAL |
| ANDA | ANDA065188 |
| FDA SPL set id | 802523 |
| Labeler | WG Critical Care, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2005-11-25 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 44567-212 |
NDC Item 55150011801
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-01 |
| NDC Item | 55150011801 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 55150011899
| NDC 9 | 55150-118 |
|---|---|
| NDC 10 | 55150-118-99 |
| NDC Item | 55150011899 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-118-99) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090339 |
| COLORTEXT | WHITE(White to Off-white) |
| Color | C48325 __ |
| FDA SPL set id | 705808 |
| FDA SPL set id | 790102 |
| Labeler | Eugia US LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2012-02-10 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 55150-118 |
NDC Item 63323037062
| NDC 9 | 63323-370 |
|---|---|
| NDC 10 | 63323-370-62 |
| NDC Item | 63323037062 |
| Packaging | 10 VIAL in 1 CARTON (63323-370-62) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL |
| ANDA | ANDA065314 |
| FDA SPL set id | 440211 |
| Labeler | Fresenius Kabi USA, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 63323-370 |
NDC Item 66794020815
| NDC 9 | 66794-208 |
|---|---|
| NDC 10 | 66794-208-15 |
| NDC Item | 66794020815 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-208-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 683048 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-208 |
NDC Item 66794024315
| NDC 9 | 66794-243 |
|---|---|
| NDC 10 | 66794-243-15 |
| NDC Item | 66794024315 |
| Packaging | 1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 695618 |
| Labeler | Piramal Critical Care Inc |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2019-05-20 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 66794-243 |
NDC Item 67457064910
| NDC 9 | 67457-649 |
|---|---|
| NDC 10 | 67457-649-10 |
| NDC Item | 67457064910 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67457-649-10) / 92 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA202197 |
| FDA SPL set id | 675550 |
| Labeler | Mylan Institutional LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2023-12-31 |
| Marketing effective time low | 2014-04-08 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 67457-649 |
NDC Item 70594008301
| NDC 9 | 70594-083 |
|---|---|
| NDC 10 | 70594-083-01 |
| NDC Item | 70594008301 |
| Packaging | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-083-01) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ANDA | ANDA090578 |
| FDA SPL set id | 839900 |
| Labeler | Xellia Pharmaceuticals USA LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2025-12-31 |
| Marketing effective time low | 2021-01-10 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 70594-083 |
NDC Item 71288000775
| NDC 9 | 71288-007 |
|---|---|
| NDC 10 | 71288-007-75 |
| NDC Item | 71288000775 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-007-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA090578 |
| FDA SPL set id | 770217 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time high | 2024-07-31 |
| Marketing effective time low | 2018-12-17 |
| Marketing status | COMPLETED |
| Related queries | Properties for NDC 9 71288-007 |
NDC Item 71288003375
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-75 |
| NDC Item | 71288003375 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-75) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 71288003391
| NDC 9 | 71288-033 |
|---|---|
| NDC 10 | 71288-033-91 |
| NDC Item | 71288003391 |
| Packaging | 1 BOTTLE in 1 CARTON (71288-033-91) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 787683 |
| FDA SPL set id | 873626 |
| Labeler | Meitheal Pharmaceuticals Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2006-11-27 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 71288-033 |
NDC Item 72603044401
| NDC 9 | 72603-444 |
|---|---|
| NDC 10 | 72603-444-01 |
| NDC Item | 72603044401 |
| Packaging | 10 BOTTLE in 1 CARTON (72603-444-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 793826 |
| Labeler | NorthStar Rx, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2024-03-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 72603-444 |
NDC Item 83634010899
| NDC 9 | 83634-108 |
|---|---|
| NDC 10 | 83634-108-99 |
| NDC Item | 83634010899 |
| Packaging | 1 BOTTLE in 1 CARTON (83634-108-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE |
| ANDA | ANDA065314 |
| FDA SPL set id | 857432 |
| Labeler | Avenacy Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | ANDA |
| Marketing effective time low | 2025-02-01 |
| Marketing status | ACTIVE |
| Related queries | Properties for NDC 9 83634-108 |