cefdinir

Generic: cefdinir

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

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler nucare pharmaceuticals,inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefdinir 250 mg/5mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3403
Product ID 68071-3403_2d540607-1806-4063-e063-6294a90a7159
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065259
Listing Expiration 2026-12-31
Marketing Start 2007-05-07

Pharmacologic Class

Established (EPC)
cephalosporin antibacterial [epc]
Chemical Structure
cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713403
Hyphenated Format 68071-3403

Supplemental Identifiers

RxCUI
476576
UPC
0368071340310
UNII
CI0FAO63WC
NUI
N0000175488 M0003827

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 cefdinir (source: ndc)
Generic Name cefdinir (source: ndc)
Application Number ANDA065259 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (68071-3403-1)
source: ndc

Packages (1)

68071-3403-1 100 mL in 1 BOTTLE (68071-3403-1)

Ingredients (1)

cefdinir (250 mg/5mL)

Linked Drug Pages (1)

Cefdinir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d540607-1806-4063-e063-6294a90a7159", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0368071340310"], "unii": ["CI0FAO63WC"], "rxcui": ["476576"], "spl_set_id": ["fbd76f8c-e6b8-52f4-e053-6394a90aa7ab"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (68071-3403-1)", "package_ndc": "68071-3403-1", "marketing_start_date": "20230516"}], "brand_name": "Cefdinir", "product_id": "68071-3403_2d540607-1806-4063-e063-6294a90a7159", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68071-3403", "generic_name": "Cefdinir", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "250 mg/5mL"}], "application_number": "ANDA065259", "marketing_category": "ANDA", "marketing_start_date": "20070507", "listing_expiration_date": "20261231"}