terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler nucare pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4500
Product ID 68071-4500_1a8daeb9-2c25-ccc0-e063-6394a90a9cae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077714
Listing Expiration 2026-12-31
Marketing Start 2010-12-27

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714500
Hyphenated Format 68071-4500

Supplemental Identifiers

RxCUI
313222
UPC
0368071450019
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
  • 100 TABLET in 1 BOTTLE (68071-4500-1)
source: ndc

Packages (1)

68071-4500-1 100 TABLET in 1 BOTTLE (68071-4500-1)

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": "1a8daeb9-2c25-ccc0-e063-6394a90a9cae", "openfda": {"upc": ["0368071450019"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["715cae3e-4e86-48b3-e053-2a95a90afdc2"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68071-4500-1)", "package_ndc": "68071-4500-1", "marketing_start_date": "20180719"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "68071-4500_1a8daeb9-2c25-ccc0-e063-6394a90a9cae", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "68071-4500", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "20101227", "listing_expiration_date": "20261231"}