terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-2080
Product ID 51672-2080_4b425c57-bf63-6851-e063-6394a90ac6e7
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Listing Expiration 2027-12-31
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 516722080
Hyphenated Format 51672-2080

Supplemental Identifiers

RxCUI
992528
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 hydrochloride (source: ndc)
Generic Name terbinafine hydrochloride (source: ndc)
Application Number ANDA077511 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (51672-2080-1) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-2) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-3) / 60 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-4) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-6) / 45 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-8) / 12 g in 1 TUBE
  • 1 TUBE in 1 CARTON (51672-2080-9) / 24 g in 1 TUBE
source: ndc

Packages (7)

51672-2080-1 1 TUBE in 1 CARTON (51672-2080-1) / 15 g in 1 TUBE 51672-2080-2 1 TUBE in 1 CARTON (51672-2080-2) / 30 g in 1 TUBE 51672-2080-3 1 TUBE in 1 CARTON (51672-2080-3) / 60 g in 1 TUBE 51672-2080-4 1 TUBE in 1 CARTON (51672-2080-4) / 15 g in 1 TUBE 51672-2080-6 1 TUBE in 1 CARTON (51672-2080-6) / 45 g in 1 TUBE 51672-2080-8 1 TUBE in 1 CARTON (51672-2080-8) / 12 g in 1 TUBE 51672-2080-9 1 TUBE in 1 CARTON (51672-2080-9) / 24 g in 1 TUBE

Ingredients (1)

terbinafine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Terbinafine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4b425c57-bf63-6851-e063-6394a90ac6e7", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["92b31fc4-0f02-4857-b11f-49b9f942ee84"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-1)  / 15 g in 1 TUBE", "package_ndc": "51672-2080-1", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-2)  / 30 g in 1 TUBE", "package_ndc": "51672-2080-2", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-3)  / 60 g in 1 TUBE", "package_ndc": "51672-2080-3", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-4)  / 15 g in 1 TUBE", "package_ndc": "51672-2080-4", "marketing_start_date": "20170424"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-6)  / 45 g in 1 TUBE", "package_ndc": "51672-2080-6", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-8)  / 12 g in 1 TUBE", "package_ndc": "51672-2080-8", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (51672-2080-9)  / 24 g in 1 TUBE", "package_ndc": "51672-2080-9", "marketing_start_date": "20070702"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "51672-2080_4b425c57-bf63-6851-e063-6394a90ac6e7", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "51672-2080", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Terbinafine Hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "ANDA077511", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20271231"}