silka antifungal

Generic: terbinafine hydrochloride

Labeler: genomma lab usa, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name silka antifungal
Generic Name terbinafine hydrochloride
Labeler genomma lab usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Genomma Lab USA, Inc.

Identifiers & Regulatory

Product NDC 50066-080
Product ID 50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
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 50066080
Hyphenated Format 50066-080

Supplemental Identifiers

RxCUI
992528 1739221
UPC
0650066000485
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 silka antifungal (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 (50066-080-02) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE
source: ndc

Packages (3)

50066-080-02 1 TUBE in 1 CARTON (50066-080-02) / 30 g in 1 TUBE 50066-080-03 1 TUBE in 1 CARTON (50066-080-03) / 30 g in 1 TUBE 50066-080-05 1 TUBE in 1 CARTON (50066-080-05) / 15 g in 1 TUBE

Ingredients (1)

terbinafine hydrochloride (1 g/100g)

Linked Drug Pages (1)

Silka Antifungal ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "38f62b9e-4081-44e8-e063-6394a90a1f3a", "openfda": {"upc": ["0650066000485"], "unii": ["012C11ZU6G"], "rxcui": ["992528", "1739221"], "spl_set_id": ["a32cf699-e63e-4bd3-a5af-9e1ba447e02e"], "manufacturer_name": ["Genomma Lab USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (50066-080-02)  / 30 g in 1 TUBE", "package_ndc": "50066-080-02", "marketing_start_date": "20070702"}, {"sample": false, "description": "1 TUBE in 1 CARTON (50066-080-03)  / 30 g in 1 TUBE", "package_ndc": "50066-080-03", "marketing_start_date": "20180521"}, {"sample": false, "description": "1 TUBE in 1 CARTON (50066-080-05)  / 15 g in 1 TUBE", "package_ndc": "50066-080-05", "marketing_start_date": "20181220"}], "brand_name": "Silka Antifungal", "product_id": "50066-080_38f62b9e-4081-44e8-e063-6394a90a1f3a", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "50066-080", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Genomma Lab USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Silka", "brand_name_suffix": "Antifungal", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "1 g/100g"}], "application_number": "ANDA077511", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20261231"}