POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE
- Product NDC
- 60758-908
- Requested package NDC
- 60758-908-10
- 11-digit product format
- 607580908
- Labeler code
- 60758
- Product ID
- 60758-908_4bda8610-a14c-45ca-8caa-5fb3afce314e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- polymyxin B sulfate, trimethoprim sulfate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Pacific Pharma, Inc.
- Application
- NDA050567
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1997-04-29
- 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
- 2022-12-31
- 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 package | package | 60758-908 | 60758-908-10 | D | Discontinued by firm | 2026-08-11 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050567-001 | POLYTRIM | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050567-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050567-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050567-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050567-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050567-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050567-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050567-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050567-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050567-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050567-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050567-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050567-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050567-001 | AT | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | N050567-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050567-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050567-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050567-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050567-001 | AT | 1 | cb3db0bc1861… |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60758-908-10 | ML - Milliliter | 60758-908 | c9a05a15-dd5c-4c45-a7ec-3e91a5487221 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 | 0461401a-17c1-460f-b9ec-ff1cfe514f57 | 2 |
| 244967 | polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution | SCD | 0461401a-17c1-460f-b9ec-ff1cfe514f57 | 2 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution | SY | 0461401a-17c1-460f-b9ec-ff1cfe514f57 | 2 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution | SY | 0461401a-17c1-460f-b9ec-ff1cfe514f57 | 2 |
| 244967 | Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution | SY | 0461401a-17c1-460f-b9ec-ff1cfe514f57 | 2 |
| 244967 | polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution | PSN | 1fc0731a-fb78-240f-e063-6394a90a6950 | 1 |
| 244967 | polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution | SCD | 1fc0731a-fb78-240f-e063-6394a90a6950 | 1 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution | SY | 1fc0731a-fb78-240f-e063-6394a90a6950 | 1 |
| 244967 | polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution | SY | 1fc0731a-fb78-240f-e063-6394a90a6950 | 1 |
| 244967 | Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution | SY | 1fc0731a-fb78-240f-e063-6394a90a6950 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 60758-908-10 | 60758090810 | 1 BOTTLE, DROPPER in 1 CARTON (60758-908-10) > 10 mL in 1 BOTTLE, DROPPER | 1997-04-29 | 0000-00-00 | No | No | Current |