terbinafine

Generic: terbinafine

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

Drug Facts

Product Profile

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

terbinafine hydrochloride 250 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-859
Product ID 69097-859_e3db8f4b-ea51-41b6-859e-ad91677aaf73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077533
Listing Expiration 2026-12-31
Marketing Start 2016-06-27

Pharmacologic Class

Classes
allylamine antifungal [epc] allylamine [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097859
Hyphenated Format 69097-859

Supplemental Identifiers

RxCUI
313222
UPC
0369097859022
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 ANDA077533 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (69097-859-02)
  • 100 TABLET in 1 BOTTLE (69097-859-07)
  • 500 TABLET in 1 BOTTLE (69097-859-12)
source: ndc

Packages (3)

69097-859-02 30 TABLET in 1 BOTTLE (69097-859-02) 69097-859-07 100 TABLET in 1 BOTTLE (69097-859-07) 69097-859-12 500 TABLET in 1 BOTTLE (69097-859-12)

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": "e3db8f4b-ea51-41b6-859e-ad91677aaf73", "openfda": {"upc": ["0369097859022"], "unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["18b16aad-1877-4b07-b532-f0ef4843af91"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (69097-859-02)", "package_ndc": "69097-859-02", "marketing_start_date": "20160627"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69097-859-07)", "package_ndc": "69097-859-07", "marketing_start_date": "20160627"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (69097-859-12)", "package_ndc": "69097-859-12", "marketing_start_date": "20160627"}], "brand_name": "Terbinafine", "product_id": "69097-859_e3db8f4b-ea51-41b6-859e-ad91677aaf73", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "69097-859", "generic_name": "Terbinafine", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA077533", "marketing_category": "ANDA", "marketing_start_date": "20160627", "listing_expiration_date": "20261231"}