Home NDC 0054-0975 Neomycin and Polymyxin B sulfates and Hydrocortisone
Product NDC 0054-0975
11-digit product format 000540975
Labeler code 0054
Product ID 0054-0975_aefabd5a-1362-4384-9ebf-9ee2492f4063
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Neomycin and Polymyxin B sulfates and Hydrocortisone
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA220938
Marketing category ANDA
Marketing start 2026-10-08
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength 3.5; 10000; 10 mg/mL; [iU]/mL; mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], 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 A220938-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2026-08-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220938-001 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 A220938-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2026-08-27 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220938-001 AT 1 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0054-0975-80 00054097580 1 BOTTLE, DROPPER in 1 CARTON (0054-0975-80) / 10 mL in 1 BOTTLE, DROPPER 2026-10-08 No No Historical