terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: walgreen company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler walgreen company
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
WALGREEN COMPANY

Identifiers & Regulatory

Product NDC 0363-4502
Product ID 0363-4502_3996583d-a3da-fa4a-e063-6394a90af78a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Listing Expiration 2026-12-31
Marketing Start 2023-10-25

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03634502
Hyphenated Format 0363-4502

Supplemental Identifiers

RxCUI
992528
UNII
012C11ZU6G

Packaging Origin

Original Packager
true

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 (0363-4502-02) / 30 g in 1 TUBE
source: ndc

Packages (1)

0363-4502-02 1 TUBE in 1 CARTON (0363-4502-02) / 30 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": "3996583d-a3da-fa4a-e063-6394a90af78a", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["2ba1924b-9967-4adb-9061-d023ef44ab3e"], "manufacturer_name": ["WALGREEN COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (0363-4502-02)  / 30 g in 1 TUBE", "package_ndc": "0363-4502-02", "marketing_start_date": "20231025"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "0363-4502_3996583d-a3da-fa4a-e063-6394a90af78a", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "0363-4502", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "WALGREEN COMPANY", "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": "20231025", "listing_expiration_date": "20261231"}