terbinafine

Generic: terbinafine hydrochloride

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine hydrochloride
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-795
Product ID 16714-795_959f3136-b10d-4a73-a11a-1fae5bd72fb6
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 16714795
Hyphenated Format 16714-795

Supplemental Identifiers

RxCUI
313222
UNII
012C11ZU6G

Packaging Origin

Original Packager
true

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 (16714-795-01)
  • 100 TABLET in 1 BOTTLE (16714-795-02)
source: ndc

Packages (2)

16714-795-01 30 TABLET in 1 BOTTLE (16714-795-01) 16714-795-02 100 TABLET in 1 BOTTLE (16714-795-02)

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": "959f3136-b10d-4a73-a11a-1fae5bd72fb6", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["8f87e3e1-4c9c-497a-af20-8ab52cfeef60"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16714-795-01)", "package_ndc": "16714-795-01", "marketing_start_date": "20070702"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (16714-795-02)", "package_ndc": "16714-795-02", "marketing_start_date": "20070702"}], "brand_name": "Terbinafine", "product_id": "16714-795_959f3136-b10d-4a73-a11a-1fae5bd72fb6", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "16714-795", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "NorthStar Rx LLC", "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"}