terbinafine

Generic: terbinafine

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

Drug Facts

Product Profile

Brand Name terbinafine
Generic Name terbinafine
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-572
Product ID 62135-572_2659c503-319a-b899-e063-6294a90aa6a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078199
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 62135572
Hyphenated Format 62135-572

Supplemental Identifiers

RxCUI
313222
UPC
0362135572907 0362135572303
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 (source: ndc)
Application Number ANDA078199 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (62135-572-30)
  • 90 TABLET in 1 BOTTLE (62135-572-90)
source: ndc

Packages (2)

62135-572-30 30 TABLET in 1 BOTTLE (62135-572-30) 62135-572-90 90 TABLET in 1 BOTTLE (62135-572-90)

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": "2659c503-319a-b899-e063-6294a90aa6a6", "openfda": {"upc": ["0362135572907", "0362135572303"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["8ea693ec-e2f2-4661-b144-17651018e9fb"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-572-30)", "package_ndc": "62135-572-30", "marketing_start_date": "20220308"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-572-90)", "package_ndc": "62135-572-90", "marketing_start_date": "20220308"}], "brand_name": "TERBINAFINE", "product_id": "62135-572_2659c503-319a-b899-e063-6294a90aa6a6", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "62135-572", "generic_name": "Terbinafine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERBINAFINE", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA078199", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20261231"}