NDC properties for "Tobradex (dexamethasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension" (RxCUI 1011080)
About this data
The tables show NDC propoerties for Tobradex (dexamethasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension with the RxCUI 1011080
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 Tobradex (dexamethasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension (RxCUI 1011080)
| MMSL_CODE | BD25033 |
|---|---|
| NDA | NDA050818 |
| RxCUI | 1011080 |
| SPL_SET_ID | 3b99dbb3-ac84-4d0d-b30f-a5db44fdc316 |
| SPL_SET_ID | c2d7325e-4f58-5590-e053-2a95a90ace1b |
| Prescribable Synonym | TobraDex ST 0.3 % / 0.05 % Ophthalmic Suspension |
| RXNAV_STR | Tobradex (dexAMETHasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension |
| RxNorm Name | dexamethasone 0.5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex] |
| RxNorm Synonym | Tobradex (dexamethasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension |
| Tallman Synonym | dexAMETHasone 0.5 MG/ML / tobramycin 3 MG/ML Ophthalmic Suspension [Tobradex] |
| Tallman Synonym | Tobradex (dexAMETHasone 0.05 % / tobramycin 0.3 % ) Ophthalmic Suspension |
| Related queries | Interactions (for RxCUI 1011080) |
NDC Properties
NDC Item 00065065205
| NDC 9 | 0065-0652 |
|---|---|
| NDC 10 | 0065-0652-05 |
| NDC Item | 00065065205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 525776 |
| Labeler | Alcon Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time high | 2021-06-30 |
| Marketing effective time low | 2010-09-07 |
| Marketing status | COMPLETED |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 0065-0652 |
NDC Item 71776003501
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-01 |
| NDC Item | 71776003501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 71776003505
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-05 |
| NDC Item | 71776003505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 82667001100
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-00 |
| NDC Item | 82667001100 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 82667001105
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-05 |
| NDC Item | 82667001105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 00065065205
| NDC 9 | 0065-0652 |
|---|---|
| NDC 10 | 0065-0652-05 |
| NDC Item | 00065065205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 525776 |
| Labeler | Alcon Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time high | 2021-06-30 |
| Marketing effective time low | 2010-09-07 |
| Marketing status | COMPLETED |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 0065-0652 |
NDC Item 71776003501
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-01 |
| NDC Item | 71776003501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 71776003505
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-05 |
| NDC Item | 71776003505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 82667001100
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-00 |
| NDC Item | 82667001100 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 82667001105
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-05 |
| NDC Item | 82667001105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 00065065205
| NDC 9 | 0065-0652 |
|---|---|
| NDC 10 | 0065-0652-05 |
| NDC Item | 00065065205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 525776 |
| Labeler | Alcon Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time high | 2021-06-30 |
| Marketing effective time low | 2010-09-07 |
| Marketing status | COMPLETED |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 0065-0652 |
NDC Item 71776003501
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-01 |
| NDC Item | 71776003501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 71776003505
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-05 |
| NDC Item | 71776003505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 82667001100
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-00 |
| NDC Item | 82667001100 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 82667001105
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-05 |
| NDC Item | 82667001105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 00065065205
| NDC 9 | 0065-0652 |
|---|---|
| NDC 10 | 0065-0652-05 |
| NDC Item | 00065065205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 525776 |
| Labeler | Alcon Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time high | 2021-06-30 |
| Marketing effective time low | 2010-09-07 |
| Marketing status | COMPLETED |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 0065-0652 |
NDC Item 71776003501
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-01 |
| NDC Item | 71776003501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 71776003505
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-05 |
| NDC Item | 71776003505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 82667001100
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-00 |
| NDC Item | 82667001100 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 82667001105
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-05 |
| NDC Item | 82667001105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 00065065205
| NDC 9 | 0065-0652 |
|---|---|
| NDC 10 | 0065-0652-05 |
| NDC Item | 00065065205 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (0065-0652-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 525776 |
| Labeler | Alcon Laboratories, Inc. |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time high | 2021-06-30 |
| Marketing effective time low | 2010-09-07 |
| Marketing status | COMPLETED |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 0065-0652 |
NDC Item 71776003501
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-01 |
| NDC Item | 71776003501 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-01) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 71776003505
| NDC 9 | 71776-035 |
|---|---|
| NDC 10 | 71776-035-05 |
| NDC Item | 71776003505 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (71776-035-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 854678 |
| Labeler | Eyevance Pharmaceuticals, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2021-05-19 |
| Marketing status | ACTIVE |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 71776-035 |
NDC Item 82667001100
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-00 |
| NDC Item | 82667001100 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |
NDC Item 82667001105
| NDC 9 | 82667-011 |
|---|---|
| NDC 10 | 82667-011-05 |
| NDC Item | 82667001105 |
| Packaging | 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER |
| FDA SPL set id | 868053 |
| Labeler | Harrow Eye, LLC |
| Label type | HUMAN PRESCRIPTION DRUG |
| Marketing category | NDA |
| Marketing effective time low | 2025-03-31 |
| Marketing status | active |
| NDA | NDA050818 |
| Related queries | Properties for NDC 9 82667-011 |