terbinafine

Generic: terbinafine

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

Drug Facts

Product Profile

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

terbinafine hydrochloride 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4421
Product ID 70518-4421_46904a73-bc1d-58d2-e063-6294a90afd89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077533
Listing Expiration 2026-12-31
Marketing Start 2025-08-04

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184421
Hyphenated Format 70518-4421

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 ANDA077533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0)
  • 45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)
  • 30 TABLET in 1 BLISTER PACK (70518-4421-2)
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3)
source: ndc

Packages (4)

70518-4421-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0) 70518-4421-1 45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1) 70518-4421-2 30 TABLET in 1 BLISTER PACK (70518-4421-2) 70518-4421-3 30 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3)

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": "46904a73-bc1d-58d2-e063-6294a90afd89", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["cacf5fe4-8c24-47ed-9a2b-b70aa5d45ef2"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0)", "package_ndc": "70518-4421-0", "marketing_start_date": "20250804"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1)", "package_ndc": "70518-4421-1", "marketing_start_date": "20250822"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-4421-2)", "package_ndc": "70518-4421-2", "marketing_start_date": "20250902"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3)", "package_ndc": "70518-4421-3", "marketing_start_date": "20250910"}], "brand_name": "Terbinafine", "product_id": "70518-4421_46904a73-bc1d-58d2-e063-6294a90afd89", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "70518-4421", "generic_name": "Terbinafine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077533", "marketing_category": "ANDA", "marketing_start_date": "20250804", "listing_expiration_date": "20261231"}