terbinafine hydrochloride

Generic: terbinafine hydrochloride

Labeler: dr.reddys laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name terbinafine hydrochloride
Generic Name terbinafine hydrochloride
Labeler dr.reddys laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

terbinafine hydrochloride 250 mg/1

Manufacturer
Dr.Reddys Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-250
Product ID 55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076390
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 55111250
Hyphenated Format 55111-250

Supplemental Identifiers

RxCUI
313222
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 hydrochloride (source: ndc)
Application Number ANDA076390 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (55111-250-01)
  • 500 TABLET in 1 BOTTLE (55111-250-05)
  • 30 TABLET in 1 BOTTLE (55111-250-30)
  • 10 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78)
  • 90 TABLET in 1 BOTTLE (55111-250-90)
source: ndc

Packages (5)

55111-250-01 100 TABLET in 1 BOTTLE (55111-250-01) 55111-250-05 500 TABLET in 1 BOTTLE (55111-250-05) 55111-250-30 30 TABLET in 1 BOTTLE (55111-250-30) 55111-250-79 10 BLISTER PACK in 1 CARTON (55111-250-79) / 10 TABLET in 1 BLISTER PACK (55111-250-78) 55111-250-90 90 TABLET in 1 BOTTLE (55111-250-90)

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": "9c427fa5-f0ef-593a-376a-0de7943c4057", "openfda": {"unii": ["012C11ZU6G"], "rxcui": ["313222"], "spl_set_id": ["e0b309a5-bebe-c6da-2847-bda21aa488b1"], "manufacturer_name": ["Dr.Reddys Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (55111-250-01)", "package_ndc": "55111-250-01", "marketing_start_date": "20070702"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (55111-250-05)", "package_ndc": "55111-250-05", "marketing_start_date": "20070702"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (55111-250-30)", "package_ndc": "55111-250-30", "marketing_start_date": "20070702"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (55111-250-79)  / 10 TABLET in 1 BLISTER PACK (55111-250-78)", "package_ndc": "55111-250-79", "marketing_start_date": "20070702"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (55111-250-90)", "package_ndc": "55111-250-90", "marketing_start_date": "20070702"}], "brand_name": "Terbinafine Hydrochloride", "product_id": "55111-250_9c427fa5-f0ef-593a-376a-0de7943c4057", "dosage_form": "TABLET", "pharm_class": ["Allylamine Antifungal [EPC]", "Allylamine [CS]"], "product_ndc": "55111-250", "generic_name": "Terbinafine Hydrochloride", "labeler_name": "Dr.Reddys Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Terbinafine Hydrochloride", "active_ingredients": [{"name": "TERBINAFINE HYDROCHLORIDE", "strength": "250 mg/1"}], "application_number": "ANDA076390", "marketing_category": "ANDA", "marketing_start_date": "20070702", "listing_expiration_date": "20261231"}