terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 43353-893
Product ID 43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077714
Listing Expiration 2026-12-31
Marketing Start 2012-08-22

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43353893
Hyphenated Format 43353-893

Supplemental Identifiers

RxCUI
313222
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 ANDA077714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6000 TABLET in 1 BOTTLE (43353-893-16)
source: ndc

Packages (1)

43353-893-16 6000 TABLET in 1 BOTTLE (43353-893-16)

Ingredients (1)

terbinafine hydrochloride (250 mg/1)

Linked Drug Pages (1)

Terbinafine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "280bbc43-14a1-47e0-a702-8cd8117c2978", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["808dab18-43f1-4895-a023-edbde722863e"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "6000 TABLET in 1 BOTTLE (43353-893-16)", "package_ndc": "43353-893-16", "marketing_start_date": "20140226"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "43353-893_280bbc43-14a1-47e0-a702-8cd8117c2978", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "43353-893", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine Hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077714", "marketing_category": "ANDA", "marketing_start_date": "20120822", "listing_expiration_date": "20261231"}