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 50090-3575
Product ID 50090-3575_d94fe835-d140-489d-853a-cbd1c0d6a62d
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 500903575
Hyphenated Format 50090-3575

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 (50090-3575-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (50090-3575-1)
source: ndc

Packages (2)

50090-3575-0 30 TABLET in 1 BOTTLE (50090-3575-0) 50090-3575-1 90 TABLET in 1 BOTTLE, PLASTIC (50090-3575-1)

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": "d94fe835-d140-489d-853a-cbd1c0d6a62d", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["5de4c245-7086-453b-b90a-7a1242ec2c0b"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-3575-0)", "package_ndc": "50090-3575-0", "marketing_start_date": "20180910"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (50090-3575-1)", "package_ndc": "50090-3575-1", "marketing_start_date": "20141128"}], "brand_name": "Terbinafine", "product_id": "50090-3575_d94fe835-d140-489d-853a-cbd1c0d6a62d", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "50090-3575", "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"}