cefdinir

Generic: cefdinir

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler remedyrepack inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cefdinir 300 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4169
Product ID 70518-4169_3fb8c970-60f6-da88-e063-6394a90afa2e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210220
Listing Expiration 2026-12-31
Marketing Start 2024-08-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184169
Hyphenated Format 70518-4169

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 ANDA210220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-0)
  • 30 CAPSULE in 1 BLISTER PACK (70518-4169-1)
  • 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-2)
source: ndc

Packages (3)

70518-4169-0 20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-0) 70518-4169-1 30 CAPSULE in 1 BLISTER PACK (70518-4169-1) 70518-4169-2 14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-2)

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": "3fb8c970-60f6-da88-e063-6394a90afa2e", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["a8029f7c-6353-46db-8c8c-c86a9485a14f"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "20 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-0)", "package_ndc": "70518-4169-0", "marketing_start_date": "20240827"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (70518-4169-1)", "package_ndc": "70518-4169-1", "marketing_start_date": "20241223"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE, PLASTIC (70518-4169-2)", "package_ndc": "70518-4169-2", "marketing_start_date": "20250312"}], "brand_name": "Cefdinir", "product_id": "70518-4169_3fb8c970-60f6-da88-e063-6394a90afa2e", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "70518-4169", "generic_name": "Cefdinir", "labeler_name": "REMEDYREPACK INC.", "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": "20240827", "listing_expiration_date": "20261231"}