NDC properties for NDC 9 0409-2689
NDC item 00409268901
| NDC 9 | 0409-2689 | 
|---|---|
| NDC 10 | 0409-2689-01 | 
| NDC Item | 00409268901 | 
| packaging | 10 VIAL in 1 TRAY (0409-2689-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2689-21) | 
| ANDA | ANDA065310 | 
| Labeler | Hospira, Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2006-07-25 | 
| Marketing status | ACTIVE | 
NDC item 00409268921
| NDC 9 | 0409-2689 | 
|---|---|
| NDC 10 | 0409-2689-21 | 
| NDC Item | 00409268921 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA065241 | 
| Labeler | Hospira, Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2006-07-25 | 
| Marketing status | COMPLETED | 
NDC item 00409268949
| NDC 9 | 0409-2689 | 
|---|---|
| NDC 10 | 0409-2689-49 | 
| NDC Item | 00409268949 | 
| ANDA | ANDA065241 | 
| Labeler | Hospira, Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2006-07-25 | 
| Marketing status | COMPLETED | 
NDC item 00641611601
| NDC 9 | 0641-6116 | 
|---|---|
| NDC 10 | 0641-6116-01 | 
| NDC Item | 00641611601 | 
| packaging | 1.5 g in 1 VIAL | 
| ANDA | ANDA065406 | 
| Labeler | Hikma Pharmaceuticals USA Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2009-12-22 | 
| Marketing status | ACTIVE | 
NDC item 00641611610
| NDC 9 | 0641-6116 | 
|---|---|
| NDC 10 | 0641-6116-10 | 
| NDC Item | 00641611610 | 
| packaging | 10 VIAL in 1 CARTON (0641-6116-10) / 1.5 g in 1 VIAL (0641-6116-01) | 
| ANDA | ANDA065406 | 
| Labeler | Hikma Pharmaceuticals USA Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2009-12-22 | 
| Marketing status | ACTIVE | 
NDC item 00781303270
| NDC 9 | 0781-3032 | 
|---|---|
| NDC 10 | 0781-3032-70 | 
| NDC Item | 00781303270 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA065241 | 
| Labeler | Sandoz Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2006-07-25 | 
| Marketing status | COMPLETED | 
NDC item 00781303295
| NDC 9 | 0781-3032 | 
|---|---|
| NDC 10 | 0781-3032-95 | 
| NDC Item | 00781303295 | 
| packaging | 10 VIAL in 1 CARTON (0781-3032-95) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0781-3032-70) | 
| ANDA | ANDA065241 | 
| Labeler | Sandoz Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2006-07-25 | 
| Marketing status | COMPLETED | 
NDC item 25021014220
| NDC 9 | 25021-142 | 
|---|---|
| NDC 10 | 25021-142-20 | 
| NDC Item | 25021014220 | 
| packaging | 10 VIAL in 1 CARTON (25021-142-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA065406 | 
| Labeler | Sagent Pharmaceuticals | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2010-06-30 | 
| Marketing status | ACTIVE | 
NDC item 25021018620
| NDC 9 | 25021-186 | 
|---|---|
| NDC 10 | 25021-186-20 | 
| NDC Item | 25021018620 | 
| packaging | 10 VIAL in 1 CARTON (25021-186-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA090579 | 
| 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 | 
NDC item 44567021010
| NDC 9 | 44567-210 | 
|---|---|
| NDC 10 | 44567-210-10 | 
| NDC Item | 44567021010 | 
| packaging | 10 VIAL in 1 CARTON (44567-210-10) / 10 mL in 1 VIAL | 
| ANDA | ANDA065176 | 
| Labeler | WG Critical Care, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-30 | 
| Marketing status | ACTIVE | 
NDC item 55150011601
| NDC 9 | 55150-116 | 
|---|---|
| NDC 10 | 55150-116-01 | 
| NDC Item | 55150011601 | 
| ANDA | ANDA090349 | 
| COLORTEXT | WHITE(White to Off-white) | 
| Color | C48325 __ | 
| Labeler | Eugia US LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2012-02-10 | 
| Marketing status | ACTIVE | 
NDC item 55150011610
| NDC 9 | 55150-116 | 
|---|---|
| NDC 10 | 55150-116-10 | 
| NDC Item | 55150011610 | 
| packaging | 10 VIAL in 1 CARTON (55150-116-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA090349 | 
| COLORTEXT | WHITE(White to Off-white) | 
| Color | C48325 __ | 
| Labeler | Eugia US LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2012-02-10 | 
| Marketing status | ACTIVE | 
NDC item 55150011620
| NDC 9 | 55150-116 | 
|---|---|
| NDC 10 | 55150-116-20 | 
| NDC Item | 55150011620 | 
| packaging | 10 VIAL in 1 CARTON (55150-116-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA090349 | 
| COLORTEXT | WHITE(White to Off-white) | 
| Color | C48325 __ | 
| Labeler | Eugia US LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2012-02-10 | 
| Marketing status | ACTIVE | 
NDC item 55150017899
| NDC 9 | 55150-178 | 
|---|---|
| NDC 10 | 55150-178-99 | 
| NDC Item | 55150017899 | 
| packaging | 10 BOTTLE in 1 BOX (55150-178-99) / 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE | 
| ANDA | ANDA090340 | 
| COLORTEXT | WHITE(White to Off-white) | 
| Color | C48325 __ | 
| Labeler | Eugia US LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2012-09-13 | 
| Marketing status | ACTIVE | 
NDC item 63323036820
| NDC 9 | 63323-368 | 
|---|---|
| NDC 10 | 63323-368-20 | 
| NDC Item | 63323036820 | 
| packaging | 10 VIAL in 1 CARTON (63323-368-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA065222 | 
| Labeler | Fresenius Kabi USA, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-29 | 
| Marketing status | COMPLETED | 
NDC item 66794020602
| NDC 9 | 66794-206 | 
|---|---|
| NDC 10 | 66794-206-02 | 
| NDC Item | 66794020602 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA090579 | 
| Labeler | Piramal Critical Care Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing status | COMPLETED | 
NDC item 66794020641
| NDC 9 | 66794-206 | 
|---|---|
| NDC 10 | 66794-206-41 | 
| NDC Item | 66794020641 | 
| packaging | 10 VIAL in 1 CARTON (66794-206-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-206-02) | 
| ANDA | ANDA090579 | 
| Labeler | Piramal Critical Care Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing status | COMPLETED | 
NDC item 66794024102
| NDC 9 | 66794-241 | 
|---|---|
| NDC 10 | 66794-241-02 | 
| NDC Item | 66794024102 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA090579 | 
| Labeler | Piramal Critical Care Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2022-12-31 | 
| Marketing effective time low | 2023-01-01 | 
| Marketing status | DROPPED | 
NDC item 66794024141
| NDC 9 | 66794-241 | 
|---|---|
| NDC 10 | 66794-241-41 | 
| NDC Item | 66794024141 | 
| packaging | 10 VIAL in 1 CARTON (66794-241-41) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-241-02) | 
| ANDA | ANDA090579 | 
| Labeler | Piramal Critical Care Inc | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2022-12-31 | 
| Marketing effective time low | 2023-01-01 | 
| Marketing status | DROPPED | 
NDC item 67457034810
| NDC 9 | 67457-348 | 
|---|---|
| NDC 10 | 67457-348-10 | 
| NDC Item | 67457034810 | 
| packaging | 10 VIAL in 1 CARTON (67457-348-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA201024 | 
| Labeler | Mylan Institutional LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2023-10-31 | 
| Marketing effective time low | 2014-04-08 | 
| Marketing status | COMPLETED | 
NDC item 67457034815
| NDC 9 | 67457-348 | 
|---|---|
| NDC 10 | 67457-348-15 | 
| NDC Item | 67457034815 | 
| packaging | 1 VIAL in 1 CARTON (67457-348-15) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA201024 | 
| Labeler | Mylan Institutional LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2023-10-31 | 
| Marketing effective time low | 2014-04-08 | 
| Marketing status | COMPLETED | 
NDC item 70594008101
| NDC 9 | 70594-081 | 
|---|---|
| NDC 10 | 70594-081-01 | 
| NDC Item | 70594008101 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA090579 | 
| 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 | 
NDC item 70594008102
| NDC 9 | 70594-081 | 
|---|---|
| NDC 10 | 70594-081-02 | 
| NDC Item | 70594008102 | 
| packaging | 10 VIAL in 1 CARTON (70594-081-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (70594-081-01) | 
| ANDA | ANDA090579 | 
| 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 | 
NDC item 71288000520
| NDC 9 | 71288-005 | 
|---|---|
| NDC 10 | 71288-005-20 | 
| NDC Item | 71288000520 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21) | 
| ANDA | ANDA090579 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2024-07-31 | 
| Marketing effective time low | 2022-01-17 | 
| Marketing status | COMPLETED | 
NDC item 71288000521
| NDC 9 | 71288-005 | 
|---|---|
| NDC 10 | 71288-005-21 | 
| NDC Item | 71288000521 | 
| packaging | 1 in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA090579 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time high | 2024-07-31 | 
| Marketing effective time low | 2022-01-17 | 
| Marketing status | COMPLETED | 
NDC item 71288003120
| NDC 9 | 71288-031 | 
|---|---|
| NDC 10 | 71288-031-20 | 
| NDC Item | 71288003120 | 
| packaging | 1 in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA065222 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-29 | 
| Marketing status | ACTIVE | 
NDC item 71288003121
| NDC 9 | 71288-031 | 
|---|---|
| NDC 10 | 71288-031-21 | 
| NDC Item | 71288003121 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-21) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-20) | 
| ANDA | ANDA065222 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-29 | 
| Marketing status | ACTIVE | 
NDC item 71288003191
| NDC 9 | 71288-031 | 
|---|---|
| NDC 10 | 71288-031-91 | 
| NDC Item | 71288003191 | 
| packaging | 1 in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA065222 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-29 | 
| Marketing status | ACTIVE | 
NDC item 71288003192
| NDC 9 | 71288-031 | 
|---|---|
| NDC 10 | 71288-031-92 | 
| NDC Item | 71288003192 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-031-92) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-031-91) | 
| ANDA | ANDA065222 | 
| Labeler | Meitheal Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2005-11-29 | 
| Marketing status | ACTIVE | 
NDC item 72485041601
| NDC 9 | 72485-416 | 
|---|---|
| NDC 10 | 72485-416-01 | 
| NDC Item | 72485041601 | 
| packaging | 1 in 1 VIAL | 
| ANDA | ANDA201024 | 
| COLORTEXT | white(off-white) | 
| Color | C48325 __ | 
| Labeler | Armas Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2023-07-21 | 
| Marketing status | ACTIVE | 
NDC item 72485041610
| NDC 9 | 72485-416 | 
|---|---|
| NDC 10 | 72485-416-10 | 
| NDC Item | 72485041610 | 
| packaging | 10 VIAL in 1 CARTON (72485-416-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (72485-416-01) | 
| ANDA | ANDA201024 | 
| COLORTEXT | white(off-white) | 
| Color | C48325 __ | 
| Labeler | Armas Pharmaceuticals Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2023-07-21 | 
| Marketing status | ACTIVE | 
NDC item 72572002101
| NDC 9 | 72572-021 | 
|---|---|
| NDC 10 | 72572-021-01 | 
| NDC Item | 72572002101 | 
| packaging | 1 in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA090579 | 
| Labeler | Civica, Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2022-01-10 | 
| Marketing status | COMPLETED | 
NDC item 72572002110
| NDC 9 | 72572-021 | 
|---|---|
| NDC 10 | 72572-021-10 | 
| NDC Item | 72572002110 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (72572-021-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72572-021-01) | 
| ANDA | ANDA090579 | 
| Labeler | Civica, Inc. | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2022-01-10 | 
| Marketing status | COMPLETED | 
NDC item 72603022001
| NDC 9 | 72603-220 | 
|---|---|
| NDC 10 | 72603-220-01 | 
| NDC Item | 72603022001 | 
| packaging | 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72603-220-01) | 
| ANDA | ANDA065222 | 
| Labeler | NorthStar Rx, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2024-03-01 | 
| Marketing status | ACTIVE | 
NDC item 72603022010
| NDC 9 | 72603-220 | 
|---|---|
| NDC 10 | 72603-220-10 | 
| NDC Item | 72603022010 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (72603-220-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA065222 | 
| Labeler | NorthStar Rx, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2024-03-01 | 
| Marketing status | ACTIVE | 
NDC item 82449051301
| NDC 9 | 82449-513 | 
|---|---|
| NDC 10 | 82449-513-01 | 
| NDC Item | 82449051301 | 
| packaging | 1 VIAL in 1 CARTON (82449-513-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA201024 | 
| Labeler | Steriscience Specialties Private Limited | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2023-04-14 | 
| Marketing status | ACTIVE | 
NDC item 82449051302
| NDC 9 | 82449-513 | 
|---|---|
| NDC 10 | 82449-513-02 | 
| NDC Item | 82449051302 | 
| packaging | 10 VIAL in 1 CARTON (82449-513-02) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL | 
| ANDA | ANDA201024 | 
| Labeler | Steriscience Specialties Private Limited | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2023-04-14 | 
| Marketing status | ACTIVE | 
NDC item 83634010920
| NDC 9 | 83634-109 | 
|---|---|
| NDC 10 | 83634-109-20 | 
| NDC Item | 83634010920 | 
| packaging | 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-109-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-109-41) | 
| ANDA | ANDA065222 | 
| Labeler | Avenacy, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2025-02-01 | 
| Marketing status | ACTIVE | 
NDC item 83634010941
| NDC 9 | 83634-109 | 
|---|---|
| NDC 10 | 83634-109-41 | 
| NDC Item | 83634010941 | 
| packaging | 1 in 1 VIAL, SINGLE-DOSE | 
| ANDA | ANDA065222 | 
| Labeler | Avenacy, LLC | 
| Label type | HUMAN PRESCRIPTION DRUG | 
| Marketing category | ANDA | 
| Marketing effective time low | 2025-02-01 | 
| Marketing status | ACTIVE |