cefaclor

Generic: cefaclor

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefaclor
Generic Name cefaclor
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cefaclor 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-1087
Product ID 0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065058
Listing Expiration 2026-12-31
Marketing Start 2002-09-26

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00931087
Hyphenated Format 0093-1087

Supplemental Identifiers

RxCUI
309043
UNII
69K7K19H4L

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 cefaclor (source: ndc)
Generic Name cefaclor (source: ndc)
Application Number ANDA065058 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)
source: ndc

Packages (1)

0093-1087-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)

Ingredients (1)

cefaclor (500 mg/1)

Linked Drug Pages (1)

Cefaclor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "61ec00e0-d37d-4aa4-8f50-031ee7a37ecc", "openfda": {"unii": ["69K7K19H4L"], "rxcui": ["309043"], "spl_set_id": ["0878bdc2-0410-4938-9890-96523aa81c2f"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01)", "package_ndc": "0093-1087-01", "marketing_start_date": "20020926"}], "brand_name": "Cefaclor", "product_id": "0093-1087_61ec00e0-d37d-4aa4-8f50-031ee7a37ecc", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0093-1087", "generic_name": "Cefaclor", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefaclor", "active_ingredients": [{"name": "CEFACLOR", "strength": "500 mg/1"}], "application_number": "ANDA065058", "marketing_category": "ANDA", "marketing_start_date": "20020926", "listing_expiration_date": "20261231"}