cefdinir

Generic: cefdinir

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler proficient rx lp
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefdinir monohydrate 250 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-616
Product ID 63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065332
Listing Expiration 2026-12-31
Marketing Start 2007-05-08

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187616
Hyphenated Format 63187-616

Supplemental Identifiers

RxCUI
476576
UPC
0363187616007
UNII
6E7SN358SE

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 ANDA065332 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (63187-616-00)
  • 60 mL in 1 BOTTLE (63187-616-60)
source: ndc

Packages (2)

63187-616-00 100 mL in 1 BOTTLE (63187-616-00) 63187-616-60 60 mL in 1 BOTTLE (63187-616-60)

Ingredients (1)

cefdinir monohydrate (250 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": "aec22cad-186d-4dac-9fe3-c3b4d6075b2c", "openfda": {"upc": ["0363187616007"], "unii": ["6E7SN358SE"], "rxcui": ["476576"], "spl_set_id": ["f22acd90-5dc4-406d-af78-5f9c3a674647"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (63187-616-00)", "package_ndc": "63187-616-00", "marketing_start_date": "20070508"}, {"sample": false, "description": "60 mL in 1 BOTTLE (63187-616-60)", "package_ndc": "63187-616-60", "marketing_start_date": "20070508"}], "brand_name": "Cefdinir", "product_id": "63187-616_aec22cad-186d-4dac-9fe3-c3b4d6075b2c", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "63187-616", "generic_name": "Cefdinir", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefdinir", "active_ingredients": [{"name": "CEFDINIR MONOHYDRATE", "strength": "250 mg/5mL"}], "application_number": "ANDA065332", "marketing_category": "ANDA", "marketing_start_date": "20070508", "listing_expiration_date": "20261231"}