Polymyxin B Sulfate and Trimethoprim
- Product NDC
- 53002-8621
- 11-digit product format
- 530028621
- Labeler code
- 53002
- Product ID
- 53002-8621_334a7d54-bb53-465e-a119-aa88b04d40a3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Polymyxin B Sulfate and Trimethoprim
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA064211
- Marketing category
- ANDA
- Marketing start
- 1998-04-16
- Marketing end
- 0000-00-00
- Substance
- POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
- Active strength
- 10000 [USP'U]/mL; mg/mL
- Pharmacologic classes
- Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 53002-8621 | I | Inactivated by FDA | 2026-09-09 | ||
| excluded package | package | 53002-8621 | 53002-8621-1 | I | Inactivated by FDA | 2026-09-09 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 53002-8621-1 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 53002-8621-1 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53002-8621-1 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53002-8621-1 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A064211-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1998-04-13 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A064211-001 | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | 1998-04-13 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A064211-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064211-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064211-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064211-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064211-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064211-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064211-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064211-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064211-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064211-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064211-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064211-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064211-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064211-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064211-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064211-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064211-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064211-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064211-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064211-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064211-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064211-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064211-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064211-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064211-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064211-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064211-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064211-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064211-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064211-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064211-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064211-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064211-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064211-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064211-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064211-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064211-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064211-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064211-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064211-001 | AT | 1 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ce811b5-329e-27f8-b5ff-66d52b435c00 | Product name | 3 | 20240108 |
| 8d30c4f0-0228-cea4-e3aa-f19064c47f27 | Product name | 3 | 20221128 |
| 6e20c430-5e8f-85da-1b03-f7dbc0c51fad | Product name | 3 | 20190926 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| c1381fd7-868a-f499-ef90-8f6d3e3ee6b3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-01-30 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 2023-06-07 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 2023-01-30 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 2020-12-17 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
| 2020-01-31 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP Sterile Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-8621-1 | Polymyxin B Sulfate and Trimethoprim | 10 mL in 1 BOTTLE, DROPPER | SOLUTION | 10 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-8621 | POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_76e1be2e-eb19-48d4-9bfb-88537de839ba.zip |
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 |
|---|---|---|---|---|---|---|
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Preferred Pharmacetucials Inc. | 65293418-c6ad-43d8-948c-e1949c0afc31 | 2026-08-17 | Warnings, Adverse reactions | 064211 ANDA064211 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | A-S Medication Solutions | aaa468d2-470f-43cf-b4e2-68aeb94a1e71 | 2026-02-03 | Warnings, Adverse reactions | 064211 ANDA064211 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | REMEDYREPACK INC. | 2a040ba4-54bd-41e4-b519-01ca6a59658f | 2026-01-27 | Warnings, Adverse reactions | 064211 ANDA064211 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Sandoz Inc | 71900075-5288-4f4b-afe2-098436fa2173 | 2025-09-05 | Warnings, Adverse reactions | 064211 ANDA064211 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 60f5cfcf-cdb2-0e45-e053-2991aa0ae85a | 2024-07-18 | Warnings, Adverse reactions | 064211 ANDA064211 |
| Polymyxin B Sulfate and Trimethoprim | POLYMYXIN B SULFATE AND TRIMETHOPRIM | Proficient Rx LP | 1252b997-3a81-4f3c-90e4-92f29ba15713 | 2022-04-01 | Warnings, Adverse reactions | 064211 ANDA064211 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 244967 | polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution | PSN | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution | SCD | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
| 244967 | Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution | SY | 76e1be2e-eb19-48d4-9bfb-88537de839ba | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-8621-1 | 53002862101 | 10 mL in 1 BOTTLE, DROPPER (53002-8621-1) | 10 ml | 2018-10-01 | 0000-00-00 | No | No | Current |