Polymyxin B Sulfate and Trimethoprim

Product NDC
70518-0271
11-digit product format
705180271
Labeler code
70518
Product ID
70518-0271_835e03e0-5091-ecce-e053-2991aa0a757a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Polymyxin B Sulfate and Trimethoprim Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
ANDA064120
Marketing category
ANDA
Marketing start
2017-03-02
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
2020-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-0271DDiscontinued by firm2026-09-14
excluded packagepackage70518-027170518-0271-0DDiscontinued by firm2026-09-14

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.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-0271-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-0271-0f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATEPOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A064120-001AT

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1484e616aacf4f…
2026-08-18 06:07:402026-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064120-001TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE10,000 UNITS/ML;EQ 1MG BASE/MLSOLUTION/DROPS / OPHTHALMICAT1997-02-14f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A064120-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A064120-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064120-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064120-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064120-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064120-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064120-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064120-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064120-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064120-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064120-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064120-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064120-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064120-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064120-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064120-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064120-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064120-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064120-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064120-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064120-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064120-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064120-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064120-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064120-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064120-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064120-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064120-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064120-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064120-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064120-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064120-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064120-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064120-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064120-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064120-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064120-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064120-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064120-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064120-001AT1f41ea6bd6efb…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0271POLYMYXIN B SULFATE AND TRIMETHOPRIM (POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE) SOLUTION/ DROPS [REMEDYREPACK INC.]8Legacy NDC20250425_4c7f80fc-257c-498b-bf6e-cfa982f9a3bc.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.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPreferred Pharmaceuticals Inc.31a7ad1f-3f58-41a0-94f0-36674285bb612026-03-02Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATESportpharm LLC476b8c6d-44e2-47e3-a75c-b4328dfe82a12026-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEBausch & Lomb Incorporated87999254-1857-4d3c-817a-cb8f6a5b0cf72026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATENuCare Pharmaceuticals,Inc.55e1f68a-836b-5c23-e054-00144ff88e882025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120
Polymyxin B Sulfate and TrimethoprimPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEProficient Rx LPd1f55327-156f-44cd-b0fc-b1a938e8aa732022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064120
application number: ANDA064120