terbinafine hydrochloride

Generic: terbinafine hydrochloride

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

Drug Facts

Product Profile

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

terbinafine hydrochloride 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3907
Product ID 70518-3907_3ba00ff4-7c5d-64a8-e063-6394a90a2608
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078163
Listing Expiration 2026-12-31
Marketing Start 2023-11-03

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183907
Hyphenated Format 70518-3907

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 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
  • 45 TABLET in 1 BOTTLE, PLASTIC (70518-3907-2)
source: ndc

Packages (1)

70518-3907-2 45 TABLET in 1 BOTTLE, PLASTIC (70518-3907-2)

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": "3ba00ff4-7c5d-64a8-e063-6394a90a2608", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["2886b2ff-815f-4621-bc28-1fea082c1920"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (70518-3907-2)", "package_ndc": "70518-3907-2", "marketing_start_date": "20240509"}], "brand_name": "terbinafine hydrochloride", "product_id": "70518-3907_3ba00ff4-7c5d-64a8-e063-6394a90a2608", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "70518-3907", "generic_name": "terbinafine hydrochloride", "labeler_name": "REMEDYREPACK 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": "20231103", "listing_expiration_date": "20261231"}