cefdinir

Generic: cefdinir

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cefdinir 300 mg/1

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-362
Product ID 68001-362_f80ad981-4642-03d3-e053-6394a90ab137
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065434
Listing Expiration 2026-12-31
Marketing Start 2018-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001362
Hyphenated Format 68001-362

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 ANDA065434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (68001-362-06)
source: ndc

Packages (1)

68001-362-06 60 CAPSULE in 1 BOTTLE (68001-362-06)

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": "f80ad981-4642-03d3-e053-6394a90ab137", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["e342b7cf-f527-476e-8119-b1fd81c58b55"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68001-362-06)", "package_ndc": "68001-362-06", "marketing_start_date": "20180801"}], "brand_name": "Cefdinir", "product_id": "68001-362_f80ad981-4642-03d3-e053-6394a90ab137", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68001-362", "generic_name": "Cefdinir", "labeler_name": "BluePoint Laboratories", "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": "20180801", "listing_expiration_date": "20261231"}