terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: cardinal health, 110 dba leader
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler cardinal health, 110 dba leader
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Cardinal Health, 110 dba LEADER

Identifiers & Regulatory

Product NDC 70000-0338
Product ID 70000-0338_39854f19-d8c0-6438-e063-6394a90a9422
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Listing Expiration 2026-12-31
Marketing Start 2018-07-30

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000338
Hyphenated Format 70000-0338

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 (70000-0338-1) / 15 g in 1 TUBE
source: ndc

Packages (1)

70000-0338-1 1 TUBE in 1 CARTON (70000-0338-1) / 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": "39854f19-d8c0-6438-e063-6394a90a9422", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["a9412747-c7f9-4242-91ed-3695f372f6c9"], "manufacturer_name": ["Cardinal Health, 110 dba LEADER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (70000-0338-1)  / 15 g in 1 TUBE", "package_ndc": "70000-0338-1", "marketing_start_date": "20180730"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "70000-0338_39854f19-d8c0-6438-e063-6394a90a9422", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "70000-0338", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Cardinal Health, 110 dba LEADER", "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": "20180730", "listing_expiration_date": "20261231"}