cefdinir

Generic: cefdinir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefdinir 125 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-218
Product ID 65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065473
Listing Expiration 2026-12-31
Marketing Start 2007-12-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862218
Hyphenated Format 65862-218

Supplemental Identifiers

RxCUI
309054 476576
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 ANDA065473 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65862-218-01) / 100 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65862-218-60) / 60 mL in 1 BOTTLE
source: ndc

Packages (2)

65862-218-01 1 BOTTLE in 1 CARTON (65862-218-01) / 100 mL in 1 BOTTLE 65862-218-60 1 BOTTLE in 1 CARTON (65862-218-60) / 60 mL in 1 BOTTLE

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": "9cfbe4a1-045c-489f-8ca7-9d595997dab7", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["309054", "476576"], "spl_set_id": ["06fbdb63-d32f-4212-9962-f1de15597dda"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-218-01)  / 100 mL in 1 BOTTLE", "package_ndc": "65862-218-01", "marketing_start_date": "20071214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-218-60)  / 60 mL in 1 BOTTLE", "package_ndc": "65862-218-60", "marketing_start_date": "20071214"}], "brand_name": "Cefdinir", "product_id": "65862-218_9cfbe4a1-045c-489f-8ca7-9d595997dab7", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "65862-218", "generic_name": "Cefdinir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "125 mg/5mL"}], "application_number": "ANDA065473", "marketing_category": "ANDA", "marketing_start_date": "20071214", "listing_expiration_date": "20261231"}