Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Product NDC
- 85766-249
- 11-digit product format
- 857660249
- Labeler code
- 85766
- Product ID
- 85766-249_56c7a5f6-f945-983d-e063-6294a90a8bbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Neomycin Sulfate, Polymyxin B Sulfate, Hydrocortisone
- Dosage form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Labeler
- Sportpharm LLC
- Application
- ANDA064053
- Marketing category
- ANDA
- Marketing start
- 1995-12-29
- Substance
- NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
- Active strength
- 3.5; 10000; 10 mg/mL; [USP'U]/mL; mg/mL
- Pharmacologic classes
- Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064053-001 | AT |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064053-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE | 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OTIC | AT | RS | 1995-12-29 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A064053-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A064053-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064053-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064053-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064053-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064053-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064053-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064053-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064053-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064053-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064053-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064053-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064053-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064053-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064053-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064053-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064053-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064053-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064053-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064053-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064053-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064053-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064053-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064053-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064053-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064053-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064053-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064053-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064053-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064053-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064053-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064053-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064053-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064053-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064053-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064053-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064053-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064053-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064053-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064053-001 | AT | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Neomycin and Polymyxin B Sulfates and Hydrocortisone
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NEOMYCIN SULFATE | 3.5 mg/mL |
| POLYMYXIN B SULFATE | 10000 [USP'U]/mL |
| HYDROCORTISONE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 057Y626693 | Internal UNII lookup |
| 19371312D4 | Internal UNII lookup |
| WI4X0X7BPJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 204423 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9117d5f7-9020-4e76-9bd0-a690b6dfebd3 | Available on FDA.report |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | Sportpharm LLC | 9117d5f7-9020-4e76-9bd0-a690b6dfebd3 | 2026-07-17 | Warnings, Adverse reactions | 064053 ANDA064053 85766-249 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | A-S Medication Solutions | 498f34db-89e8-49cc-8543-87da3f4344ec | 2026-02-04 | Warnings, Adverse reactions | 064053 ANDA064053 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | REMEDYREPACK INC. | 04fe1b32-adfb-4c36-a986-d81b49497e0f | 2026-01-12 | Warnings, Adverse reactions | 064053 ANDA064053 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | Bausch & Lomb Incoporated | 986e5b75-39fc-480f-9026-191b2d15dea1 | 2025-10-13 | Warnings, Adverse reactions | 064053 ANDA064053 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | NuCare Pharmaceuticals,Inc. | 5f9c25b1-67d0-11ae-e053-2a91aa0ad8f4 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | 064053 ANDA064053 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | Proficient Rx LP | d55f1783-9c49-4f90-9ff8-6f132e7b325e | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 064053 ANDA064053 |
| Neomycin and Polymyxin B Sulfates and Hydrocortisone | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE | Asclemed USA, Inc. | 7c78ec84-8b7c-42f1-a879-3bf27a1daa71 | 2020-10-30 | Boxed warning, Warnings, Adverse reactions | 064053 ANDA064053 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 85766-249-10 | 85766024910 | 1 BOTTLE, DROPPER in 1 CARTON (85766-249-10) / 10 mL in 1 BOTTLE, DROPPER | 2026-07-17 | No | No | Current |