terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler bionpharma inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-351
Product ID 69452-351_233cb04d-09cc-4312-923f-f4666bdf9754
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078163
Listing Expiration 2026-12-31
Marketing Start 2022-01-28

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69452351
Hyphenated Format 69452-351

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 ANDA078163 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (69452-351-13)
  • 100 TABLET in 1 BOTTLE, PLASTIC (69452-351-20)
source: ndc

Packages (2)

69452-351-13 30 TABLET in 1 BOTTLE, PLASTIC (69452-351-13) 69452-351-20 100 TABLET in 1 BOTTLE, PLASTIC (69452-351-20)

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": "233cb04d-09cc-4312-923f-f4666bdf9754", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["34221c17-0d8c-4b56-8af3-c74efab4599e"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (69452-351-13)", "package_ndc": "69452-351-13", "marketing_start_date": "20220128"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (69452-351-20)", "package_ndc": "69452-351-20", "marketing_start_date": "20220128"}], "brand_name": "terbinafine hydrochloride", "product_id": "69452-351_233cb04d-09cc-4312-923f-f4666bdf9754", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "69452-351", "generic_name": "terbinafine hydrochloride", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "terbinafine hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA078163", "marketing_category": "ANDA", "marketing_start_date": "20220128", "listing_expiration_date": "20261231"}