terbinafine

Generic: terbinafine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-394
Product ID 72789-394_41231fb9-9811-dfe0-e063-6294a90ab664
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 72789394
Hyphenated Format 72789-394

Supplemental Identifiers

RxCUI
313222
UPC
0372789394909
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
  • 42 TABLET in 1 BOTTLE, PLASTIC (72789-394-42)
  • 90 TABLET in 1 BOTTLE, PLASTIC (72789-394-90)
source: ndc

Packages (2)

72789-394-42 42 TABLET in 1 BOTTLE, PLASTIC (72789-394-42) 72789-394-90 90 TABLET in 1 BOTTLE, PLASTIC (72789-394-90)

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": "41231fb9-9811-dfe0-e063-6294a90ab664", "openfda": {"upc": ["0372789394909"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["747fdc13-7c3a-4672-b50c-31c51037bda2"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "42 TABLET in 1 BOTTLE, PLASTIC (72789-394-42)", "package_ndc": "72789-394-42", "marketing_start_date": "20240805"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (72789-394-90)", "package_ndc": "72789-394-90", "marketing_start_date": "20240416"}], "brand_name": "Terbinafine", "product_id": "72789-394_41231fb9-9811-dfe0-e063-6294a90ab664", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "72789-394", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}