Home NDC 57237-129 Neomycin and Polymyxin B sulfates, Bacitracin zinc
Product NDC 57237-129
11-digit product format 572370129
Labeler code 57237
Product ID 57237-129_b9658136-c2b1-492e-a9ff-8a8d4e5f5ff6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin and Polymyxin B sulfates, Bacitracin zinc
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Citron Pharma LLC
Application NDA050417
Marketing category NDA
Marketing start 2017-04-10
Marketing end 0000-00-00
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; BACITRACIN ZINC
Active strength 4 mg/g; [USP'U]/g; [USP'U]/g
Pharmacologic classes Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE],Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N050417-001 LUMI-SPORYN BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT / OPHTHALMIC AT RLD, Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050417-001 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 2026-08-01 22:54:32 2026-06 N050417-001 LUMI-SPORYN 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT / OPHTHALMIC AT RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 N050417-001 AT 1 a50c72e98297…
FDA-Initiated Inactive NDC Indexing#