terbinafine

Generic: terbinafine

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

Drug Facts

Product Profile

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

terbinafine hydrochloride 250 1/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-152
Product ID 71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077533
Listing Expiration 2026-12-31
Marketing Start 2016-06-27

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205152
Hyphenated Format 71205-152

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 1/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71205-152-15)
  • 30 TABLET in 1 BOTTLE (71205-152-30)
  • 35 TABLET in 1 BOTTLE (71205-152-35)
  • 45 TABLET in 1 BOTTLE (71205-152-45)
  • 60 TABLET in 1 BOTTLE (71205-152-60)
  • 90 TABLET in 1 BOTTLE (71205-152-90)
source: ndc

Packages (6)

71205-152-15 15 TABLET in 1 BOTTLE (71205-152-15) 71205-152-30 30 TABLET in 1 BOTTLE (71205-152-30) 71205-152-35 35 TABLET in 1 BOTTLE (71205-152-35) 71205-152-45 45 TABLET in 1 BOTTLE (71205-152-45) 71205-152-60 60 TABLET in 1 BOTTLE (71205-152-60) 71205-152-90 90 TABLET in 1 BOTTLE (71205-152-90)

Ingredients (1)

terbinafine hydrochloride (250 1/1)

Linked Drug Pages (1)

Terbinafine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "86d7ee5e-ebfd-45ea-a520-b6f65814c3e2", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["3925dc10-ad66-46a8-bfa5-1a4314be3521"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71205-152-15)", "package_ndc": "71205-152-15", "marketing_start_date": "20181101"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-152-30)", "package_ndc": "71205-152-30", "marketing_start_date": "20181101"}, {"sample": false, "description": "35 TABLET in 1 BOTTLE (71205-152-35)", "package_ndc": "71205-152-35", "marketing_start_date": "20181101"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71205-152-45)", "package_ndc": "71205-152-45", "marketing_start_date": "20181101"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-152-60)", "package_ndc": "71205-152-60", "marketing_start_date": "20181101"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-152-90)", "package_ndc": "71205-152-90", "marketing_start_date": "20181101"}], "brand_name": "Terbinafine", "product_id": "71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "71205-152", "generic_name": "Terbinafine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 1/1"}], "application_number": "ANDA077533", "marketing_category": "ANDA", "marketing_start_date": "20160627", "listing_expiration_date": "20261231"}