terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler proficient rx lp
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-111
Product ID 63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992
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 63187111
Hyphenated Format 63187-111

Supplemental Identifiers

RxCUI
992528
UPC
0363187111304
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 (63187-111-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (63187-111-30) / 30 g in 1 TUBE
source: ndc

Packages (2)

63187-111-15 1 TUBE in 1 CARTON (63187-111-15) / 15 g in 1 TUBE 63187-111-30 1 TUBE in 1 CARTON (63187-111-30) / 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": "96ea8a54-d84e-4ac6-9ce1-2624f20a4992", "openfda": {"upc": ["0363187111304"], "unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["76f7525d-2005-4da8-a795-50ede6236c68"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63187-111-15)  / 15 g in 1 TUBE", "package_ndc": "63187-111-15", "marketing_start_date": "20181201"}, {"sample": false, "description": "1 TUBE in 1 CARTON (63187-111-30)  / 30 g in 1 TUBE", "package_ndc": "63187-111-30", "marketing_start_date": "20181201"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "63187-111_96ea8a54-d84e-4ac6-9ce1-2624f20a4992", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "63187-111", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Proficient Rx LP", "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"}