terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-364
Product ID 51655-364_48eb9f2c-1512-e77b-e063-6394a90a5b31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077714
Listing Expiration 2027-12-31
Marketing Start 2020-05-28

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655364
Hyphenated Format 51655-364

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 ANDA077714 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (51655-364-26)
source: ndc

Packages (1)

51655-364-26 90 TABLET in 1 BOTTLE (51655-364-26)

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": "48eb9f2c-1512-e77b-e063-6394a90a5b31", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["ab6f50a5-87ce-0819-e053-2a95a90a22b7"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (51655-364-26)", "package_ndc": "51655-364-26", "marketing_start_date": "20200528"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "51655-364_48eb9f2c-1512-e77b-e063-6394a90a5b31", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "51655-364", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine Hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077714", "marketing_category": "ANDA", "marketing_start_date": "20200528", "listing_expiration_date": "20271231"}