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 CAPSULE
Routes
ORAL
Active Ingredients

cefdinir 300 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-5145
Product ID 68071-5145_45120ef3-e746-6c39-e063-6394a90ad638
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065434
Listing Expiration 2026-12-31
Marketing Start 2008-01-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680715145
Hyphenated Format 68071-5145

Supplemental Identifiers

RxCUI
200346
UPC
0368071514520
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 ANDA065434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE (68071-5145-2)
  • 14 CAPSULE in 1 BOTTLE (68071-5145-7)
source: ndc

Packages (2)

68071-5145-2 20 CAPSULE in 1 BOTTLE (68071-5145-2) 68071-5145-7 14 CAPSULE in 1 BOTTLE (68071-5145-7)

Ingredients (1)

cefdinir (300 mg/1)

Linked Drug Pages (1)

Cefdinir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45120ef3-e746-6c39-e063-6394a90ad638", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0368071514520"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["9ba5cb2d-6272-27de-e053-2995a90a58c8"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68071-5145-2)", "package_ndc": "68071-5145-2", "marketing_start_date": "20200108"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (68071-5145-7)", "package_ndc": "68071-5145-7", "marketing_start_date": "20251203"}], "brand_name": "Cefdinir", "product_id": "68071-5145_45120ef3-e746-6c39-e063-6394a90ad638", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68071-5145", "generic_name": "Cefdinir", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "300 mg/1"}], "application_number": "ANDA065434", "marketing_category": "ANDA", "marketing_start_date": "20080107", "listing_expiration_date": "20261231"}