terbinafine

Generic: terbinafine

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine
Labeler direct rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
direct rx

Identifiers & Regulatory

Product NDC 72189-243
Product ID 72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078297
Listing Expiration 2026-12-31
Marketing Start 2021-07-23

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189243
Hyphenated Format 72189-243

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 (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 (72189-243-30)
source: ndc

Packages (1)

72189-243-30 30 TABLET in 1 BOTTLE (72189-243-30)

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": "2c28596f-8fc8-42e5-e063-6294a90a0ad6", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["c7cf55e2-f637-e2d9-e053-2995a90a6270"], "manufacturer_name": ["direct rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-243-30)", "package_ndc": "72189-243-30", "marketing_start_date": "20210723"}], "brand_name": "TERBINAFINE", "product_id": "72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "72189-243", "generic_name": "TERBINAFINE", "labeler_name": "direct rx", "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": "20210723", "listing_expiration_date": "20261231"}