cefdinir

Generic: cefdinir

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler pd-rx pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cefdinir 300 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-959
Product ID 43063-959_415f33e2-3d2e-2637-e063-6294a90affb1
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 43063959
Hyphenated Format 43063-959

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 ANDA065434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-14)
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-20)
source: ndc

Packages (2)

43063-959-14 14 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-14) 43063-959-20 20 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-20)

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": "415f33e2-3d2e-2637-e063-6294a90affb1", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["e296387e-eb20-4451-a184-f91748a4e9c7"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-14)", "package_ndc": "43063-959-14", "marketing_start_date": "20240312"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (43063-959-20)", "package_ndc": "43063-959-20", "marketing_start_date": "20190401"}], "brand_name": "Cefdinir", "product_id": "43063-959_415f33e2-3d2e-2637-e063-6294a90affb1", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "43063-959", "generic_name": "Cefdinir", "labeler_name": "PD-Rx 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"}