terbinafine

Generic: terbinafine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-492
Product ID 71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f
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 71205492
Hyphenated Format 71205-492

Supplemental Identifiers

RxCUI
313222
UPC
0371205492304
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
  • 30 TABLET in 1 BOTTLE (71205-492-30)
  • 35 TABLET in 1 BOTTLE (71205-492-35)
  • 42 TABLET in 1 BOTTLE (71205-492-42)
  • 45 TABLET in 1 BOTTLE (71205-492-45)
  • 60 TABLET in 1 BOTTLE (71205-492-60)
  • 90 TABLET in 1 BOTTLE (71205-492-90)
source: ndc

Packages (6)

71205-492-30 30 TABLET in 1 BOTTLE (71205-492-30) 71205-492-35 35 TABLET in 1 BOTTLE (71205-492-35) 71205-492-42 42 TABLET in 1 BOTTLE (71205-492-42) 71205-492-45 45 TABLET in 1 BOTTLE (71205-492-45) 71205-492-60 60 TABLET in 1 BOTTLE (71205-492-60) 71205-492-90 90 TABLET in 1 BOTTLE (71205-492-90)

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": "bfd48470-04e9-46cb-857b-10d014b5ae1f", "openfda": {"upc": ["0371205492304"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["50657431-1cd9-42dd-9cfc-57db8713d267"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-492-30)", "package_ndc": "71205-492-30", "marketing_start_date": "20201016"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE (71205-492-35)", "package_ndc": "71205-492-35", "marketing_start_date": "20230309"}, {"sample": false, "description": "42 TABLET in 1 BOTTLE (71205-492-42)", "package_ndc": "71205-492-42", "marketing_start_date": "20240401"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71205-492-45)", "package_ndc": "71205-492-45", "marketing_start_date": "20220316"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-492-60)", "package_ndc": "71205-492-60", "marketing_start_date": "20201016"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-492-90)", "package_ndc": "71205-492-90", "marketing_start_date": "20201016"}], "brand_name": "Terbinafine", "product_id": "71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "71205-492", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Proficient Rx LP", "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"}