Home NDC 70518-4381-0 polymyxin b sulfate and trimethoprim sulfate
Product NDC 70518-4381
Requested package NDC 70518-4381-0
11-digit product format 705184381
Labeler code 70518
Product ID 70518-4381_5b0eee9a-49e3-1254-e063-6294a90a1aaf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name polymyxin b sulfate and trimethoprim sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler REMEDYREPACK INC.
Application ANDA211572
Marketing category ANDA
Marketing start 2025-07-01
Substance POLYMYXIN B SULFATE; TRIMETHOPRIM
Active strength 10000; 1 [iU]/mL; mg/mL
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211572-001 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 table 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 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211572-001 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE 10,000 UNITS/ML;EQ 1MG BASE/ML SOLUTION/DROPS / OPHTHALMIC AT 2024-08-05 a50c72e98297…
Observed Orange Book normalized TE history# 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 polymyxin b sulfate and trimethoprim sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYMYXIN B SULFATE 10000 [iU]/mL TRIMETHOPRIM 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 19371312D4 Internal UNII lookup AN164J8Y0X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 244967 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4381-0 polymyxin b sulfate and trimethoprim sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 2 70518-4381-0 polymyxin b sulfate and trimethoprim sulfate 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 2
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4381-0 70518438100 1 BOTTLE in 1 CARTON (70518-4381-0) / 10 mL in 1 BOTTLE 1 bottle 2025-07-01 No No Current