terbinafine

Generic: terbinafine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3654
Product ID 50090-3654_96cc504c-9106-48d2-a614-81ad3a4e977c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078297
Listing Expiration 2026-12-31
Marketing Start 2007-07-02

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500903654
Hyphenated Format 50090-3654

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 (source: ndc)
Generic Name terbinafine hydrochloride (source: ndc)
Application Number ANDA078297 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (50090-3654-0)
  • 90 TABLET in 1 BOTTLE (50090-3654-1)
source: ndc

Packages (2)

50090-3654-0 30 TABLET in 1 BOTTLE, PLASTIC (50090-3654-0) 50090-3654-1 90 TABLET in 1 BOTTLE (50090-3654-1)

Ingredients (1)

terbinafine hydrochloride (250 mg/1)

Linked Drug Pages (1)

Terbinafine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "96cc504c-9106-48d2-a614-81ad3a4e977c", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["79a39fb1-12b7-4b1e-9f28-102af34d0459"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (50090-3654-0)", "package_ndc": "50090-3654-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-3654-1)", "package_ndc": "50090-3654-1", "marketing_start_date": "20181011"}], "brand_name": "Terbinafine", "product_id": "50090-3654_96cc504c-9106-48d2-a614-81ad3a4e977c", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "50090-3654", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA078297", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20261231"}