terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

terbinafine hydrochloride 250 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-526
Product ID 51991-526_1603cd34-5cf4-4130-966f-c156d9237346
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 51991526
Hyphenated Format 51991-526

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (51991-526-01)
source: ndc

Packages (1)

51991-526-01 100 TABLET in 1 BOTTLE (51991-526-01)

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": "1603cd34-5cf4-4130-966f-c156d9237346", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["c3832113-f517-4b4e-bf9c-31fce1a638e1"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (51991-526-01)", "package_ndc": "51991-526-01", "marketing_start_date": "20101227"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "51991-526_1603cd34-5cf4-4130-966f-c156d9237346", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "51991-526", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Breckenridge Pharmaceutical, 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"}