cefdinir

Generic: cefdinir

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

Drug Facts

Product Profile

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

cefdinir 125 mg/5mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-327
Product ID 76420-327_331b63bf-fd36-155d-e063-6294a90aec23
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065259
Listing Expiration 2026-12-31
Marketing Start 2006-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420327
Hyphenated Format 76420-327

Supplemental Identifiers

RxCUI
309054 476576
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
  • 125 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (76420-327-01)
  • 60 mL in 1 BOTTLE (76420-327-60)
source: ndc

Packages (2)

76420-327-01 100 mL in 1 BOTTLE (76420-327-01) 76420-327-60 60 mL in 1 BOTTLE (76420-327-60)

Ingredients (1)

cefdinir (125 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": "331b63bf-fd36-155d-e063-6294a90aec23", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["309054", "476576"], "spl_set_id": ["e90660c8-2714-4592-aeaa-bc9ceb26057c"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (76420-327-01)", "package_ndc": "76420-327-01", "marketing_start_date": "20250419"}, {"sample": false, "description": "60 mL in 1 BOTTLE (76420-327-60)", "package_ndc": "76420-327-60", "marketing_start_date": "20250419"}], "brand_name": "Cefdinir", "product_id": "76420-327_331b63bf-fd36-155d-e063-6294a90aec23", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "76420-327", "generic_name": "Cefdinir", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "125 mg/5mL"}], "application_number": "ANDA065259", "marketing_category": "ANDA", "marketing_start_date": "20060531", "listing_expiration_date": "20261231"}