Home NDC 60219-2083 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Product NDC 60219-2083
11-digit product format 602192083
Labeler code 60219
Product ID 60219-2083_0c0530d7-e6e6-4c61-aee5-663933a00251
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neomycin sulfate, polymyxin b sulfate, hydrocortisone
Dosage form SOLUTION/ DROPS
Route AURICULAR (OTIC)
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA217803
Marketing category ANDA
Marketing start 2025-10-29
Substance NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
Active strength 3.5; 10000; 10 mg/mL; [USP'U]/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 2026-12-31
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 A217803-001 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 2025-10-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217803-001 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 A217803-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2025-10-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217803-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2025-10-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217803-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2025-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217803-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2025-10-29 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217803-001 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SOLUTION/DROPS / OTIC AT 2025-10-29 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 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL HYDROCORTISONE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 057Y626693 Internal UNII lookup 19371312D4 Internal UNII lookup WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204423 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 60219-2083-1 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 1 in 1 CARTON SOLUTION/ DROPS 1 5 60219-2083-1 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE 10 mL in 1 BOTTLE SOLUTION/ DROPS 10 5
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 · 1 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 60219-2083-1 60219208301 1 BOTTLE in 1 CARTON (60219-2083-1) / 10 mL in 1 BOTTLE 1 bottle 2025-10-29 No No Current