cefdinir

Generic: cefdinir

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler avkare
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cefdinir 300 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-043
Product ID 42291-043_484c12cb-6b62-1ca6-e063-6394a90a7cfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065368
Listing Expiration 2027-12-31
Marketing Start 2024-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291043
Hyphenated Format 42291-043

Supplemental Identifiers

RxCUI
200346
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 ANDA065368 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (42291-043-60)
source: ndc

Packages (1)

Ingredients (1)

cefdinir (300 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "484c12cb-6b62-1ca6-e063-6394a90a7cfb", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["1acc5d17-10a4-e23d-e063-6394a90a52c3"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (42291-043-60)", "package_ndc": "42291-043-60", "marketing_start_date": "20240613"}], "brand_name": "Cefdinir", "product_id": "42291-043_484c12cb-6b62-1ca6-e063-6394a90a7cfb", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "42291-043", "generic_name": "Cefdinir", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "300 mg/1"}], "application_number": "ANDA065368", "marketing_category": "ANDA", "marketing_start_date": "20240613", "listing_expiration_date": "20271231"}