terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: preferred pharmaceuticals, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler preferred pharmaceuticals, inc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

terbinafine hydrochloride 1 g/100g

Manufacturer
Preferred Pharmaceuticals, Inc

Identifiers & Regulatory

Product NDC 68788-9814
Product ID 68788-9814_02fc7642-968f-4ddf-a86a-146ed1a40162
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077511
Listing Expiration 2026-12-31
Marketing Start 2012-04-05

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687889814
Hyphenated Format 68788-9814

Supplemental Identifiers

RxCUI
992528
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 ANDA077511 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 15 g in 1 TUBE (68788-9814-1)
source: ndc

Packages (1)

68788-9814-1 15 g in 1 TUBE (68788-9814-1)

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": "02fc7642-968f-4ddf-a86a-146ed1a40162", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["992528"], "spl_set_id": ["6016e546-6c02-4af0-888c-c0899865c5f0"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "15 g in 1 TUBE (68788-9814-1)", "package_ndc": "68788-9814-1", "marketing_start_date": "20120405"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "68788-9814_02fc7642-968f-4ddf-a86a-146ed1a40162", "dosage_form": "CREAM", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "68788-9814", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals, 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": "20120405", "listing_expiration_date": "20261231"}