terbinafine hydrochloride

Generic: terbinafine tablets 250 mg

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine tablets 250 mg
Labeler cipla usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-731
Product ID 69097-731_feb4ee13-5f95-4a62-8395-55bad95c424b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077137
Listing Expiration 2026-12-31
Marketing Start 2021-01-08

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097731
Hyphenated Format 69097-731

Supplemental Identifiers

RxCUI
313222
UPC
0369097731021
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 tablets 250 mg (source: ndc)
Application Number ANDA077137 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-731-02)
  • 100 TABLET in 1 BOTTLE (69097-731-07)
source: ndc

Packages (2)

69097-731-02 30 TABLET in 1 BOTTLE (69097-731-02) 69097-731-07 100 TABLET in 1 BOTTLE (69097-731-07)

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": "feb4ee13-5f95-4a62-8395-55bad95c424b", "openfda": {"upc": ["0369097731021"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["daf41866-6f2b-4483-b575-456becd6e85f"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-731-02)", "package_ndc": "69097-731-02", "marketing_start_date": "20210108"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-731-07)", "package_ndc": "69097-731-07", "marketing_start_date": "20210108"}], "brand_name": "TERBINAFINE HYDROCHLORIDE", "product_id": "69097-731_feb4ee13-5f95-4a62-8395-55bad95c424b", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "69097-731", "generic_name": "Terbinafine Tablets 250 mg", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TERBINAFINE HYDROCHLORIDE", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077137", "marketing_category": "ANDA", "marketing_start_date": "20210108", "listing_expiration_date": "20261231"}