cefaclor

Generic: cefaclor

Labeler: azorian pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefaclor
Generic Name cefaclor
Labeler azorian pharma, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

cefaclor 250 mg/5mL

Manufacturer
Azorian Pharma, LLC

Identifiers & Regulatory

Product NDC 81948-6250
Product ID 81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065412
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 819486250
Hyphenated Format 81948-6250

Supplemental Identifiers

RxCUI
313888
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 ANDA065412 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 150 mL in 1 BOTTLE (81948-6250-1)
source: ndc

Packages (1)

81948-6250-1 150 mL in 1 BOTTLE (81948-6250-1)

Ingredients (1)

cefaclor (250 mg/5mL)

Linked Drug Pages (1)

Cefaclor ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a6a7fcf7-b9dc-4dac-b127-418588586a8a", "openfda": {"unii": ["69K7K19H4L"], "rxcui": ["313888"], "spl_set_id": ["224af904-38f3-4210-a750-e21006db4c66"], "manufacturer_name": ["Azorian Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "150 mL in 1 BOTTLE (81948-6250-1)", "package_ndc": "81948-6250-1", "marketing_start_date": "20221101"}], "brand_name": "Cefaclor", "product_id": "81948-6250_a6a7fcf7-b9dc-4dac-b127-418588586a8a", "dosage_form": "SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "81948-6250", "generic_name": "cefaclor", "labeler_name": "Azorian Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefaclor", "active_ingredients": [{"name": "CEFACLOR", "strength": "250 mg/5mL"}], "application_number": "ANDA065412", "marketing_category": "ANDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}