cefdinir

Generic: cefdinir

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cefdinir 300 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7563
Product ID 0904-7563_a0934baf-4745-4546-a63a-d4a660a188b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210220
Listing Expiration 2026-12-31
Marketing Start 2025-10-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047563
Hyphenated Format 0904-7563

Supplemental Identifiers

RxCUI
200346
UNII
CI0FAO63WC
NUI
N0000175488 M0003827

Packaging Origin

Original Packager
true

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 ANDA210220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0904-7563-04) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7563-04 3 BLISTER PACK in 1 CARTON (0904-7563-04) / 10 CAPSULE in 1 BLISTER PACK

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": "a0934baf-4745-4546-a63a-d4a660a188b3", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["a0934baf-4745-4546-a63a-d4a660a188b3"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0904-7563-04)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7563-04", "marketing_start_date": "20251027"}], "brand_name": "Cefdinir", "product_id": "0904-7563_a0934baf-4745-4546-a63a-d4a660a188b3", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "0904-7563", "generic_name": "Cefdinir", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "300 mg/1"}], "application_number": "ANDA210220", "marketing_category": "ANDA", "marketing_start_date": "20251027", "listing_expiration_date": "20261231"}