terbinafine hydrochloride

Generic: terbinafine hydrochloride 1g in 100g

Labeler: happy foot shop llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride 1g in 100g
Labeler happy foot shop llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Happy Foot Shop LLC

Identifiers & Regulatory

Product NDC 69983-027
Product ID 69983-027_25ba24d1-b229-8843-e063-6294a90a15bb
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Marketing Start 2024-11-15
Marketing End 2026-03-31

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69983027
Hyphenated Format 69983-027

Supplemental Identifiers

RxCUI
992528
UPC
0861185000243
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 1g in 100g (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 (69983-027-02) / 1 g in 1 TUBE
source: ndc

Packages (1)

69983-027-02 1 TUBE in 1 CARTON (69983-027-02) / 1 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": "25ba24d1-b229-8843-e063-6294a90a15bb", "openfda": {"upc": ["0861185000243"], "unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["25ba24d1-b228-8843-e063-6294a90a15bb"], "manufacturer_name": ["Happy Foot Shop LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (69983-027-02)  / 1 g in 1 TUBE", "package_ndc": "69983-027-02", "marketing_end_date": "20260331", "marketing_start_date": "20241115"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "69983-027_25ba24d1-b229-8843-e063-6294a90a15bb", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "69983-027", "generic_name": "Terbinafine Hydrochloride 1g in 100g", "labeler_name": "Happy Foot Shop LLC", "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_end_date": "20260331", "marketing_start_date": "20241115"}