Home NDC 16571-754 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Product NDC 16571-754
11-digit product format 165710754
Labeler code 16571
Product ID 16571-754_48173c90-79ed-459d-b259-947bc7952c13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin and Polymyxin B Sulfates and Bacitracin Zinc
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Rising Pharma Holdings, Inc.
Application NDA050417
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-04-07
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 Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag No
Listing certified through 2022-12-31
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400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT / OPHTHALMIC AT RLD, Approved before 1982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400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT / OPHTHALMIC AT RLD, Approved before 1982 a50c72e98297…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…
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-754 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT [RISING PHARMA HOLDINGS, INC.] 1 Legacy NDC 20211117_48173c90-79ed-459d-b259-947bc7952c13.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16571-754-53 16571075453 1 TUBE in 1 CARTON (16571-754-53) > 3.5 g in 1 TUBE 1 tube 2021-11-01 0000-00-00 No No Current