terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler a-s medication solutions
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1278
Product ID 50090-1278_d0db1c47-4dfe-443e-a514-09f727fb0b9f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Listing Expiration 2026-12-31
Marketing Start 2007-07-02

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901278
Hyphenated Format 50090-1278

Supplemental Identifiers

RxCUI
992528
UNII
012C11ZU6G

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name terbinafine hydrochloride (source: ndc)
Generic Name terbinafine hydrochloride (source: ndc)
Application Number ANDA077511 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE
source: ndc

Packages (1)

50090-1278-0 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE

Ingredients (1)

terbinafine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Terbinafine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "d0db1c47-4dfe-443e-a514-09f727fb0b9f", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["ef8370dc-8ca4-411d-87e1-dc6af3191330"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (50090-1278-0)  / 15 g in 1 TUBE", "package_ndc": "50090-1278-0", "marketing_start_date": "20141128"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "50090-1278_d0db1c47-4dfe-443e-a514-09f727fb0b9f", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "50090-1278", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Terbinafine Hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "ANDA077511", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20261231"}