Home NDC 64980-448 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Product NDC 64980-448
11-digit product format 649800448
Labeler code 64980
Product ID 64980-448_4b15047c-4c19-4562-ba03-5c1aff192a2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name neomycin and polymyxin B sulfates and hydrocortisone otic
Dosage form SUSPENSION
Route AURICULAR (OTIC)
Labeler Rising Pharma Holdings, Inc.
Application NDA060613
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2019-03-15
Substance HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength 10; 3.5; 10000 mg/mL; mg/mL; [USP'U]/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 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 N060613-001 CASPORYN HC HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OTIC AT RLD, RS, 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 N060613-001 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 N060613-001 CASPORYN HC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML SUSPENSION/DROPS / OTIC AT RLD, RS, 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 N060613-001 AT 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/mL NEOMYCIN SULFATE 3.5 mg/mL POLYMYXIN B SULFATE 10000 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup 057Y626693 Internal UNII lookup 19371312D4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310687 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 64980-448-01 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 1 in 1 CARTON SUSPENSION 1 5 64980-448-01 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension 10 mL in 1 BOTTLE SUSPENSION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-448 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC SUSPENSION (NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE OTIC) SUSPENSION [RISING PHARMA HOLDINGS, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240620_35768adc-b578-4c2e-b461-22de3135a789.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-448-01 64980044801 1 BOTTLE in 1 CARTON (64980-448-01) / 10 mL in 1 BOTTLE 1 bottle 2019-03-15 0000-00-00 No No Current