cefdinir

Generic: cefdinir

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefdinir
Generic Name cefdinir
Labeler ascend laboratories, llc
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefdinir 250 mg/5mL

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-548
Product ID 67877-548_662007e2-462e-4513-b5b0-efd5dcdc2421
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210534
Listing Expiration 2026-12-31
Marketing Start 2021-02-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877548
Hyphenated Format 67877-548

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 ANDA210534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (67877-548-88)
  • 60 mL in 1 BOTTLE (67877-548-98)
source: ndc

Packages (2)

67877-548-88 100 mL in 1 BOTTLE (67877-548-88) 67877-548-98 60 mL in 1 BOTTLE (67877-548-98)

Ingredients (1)

cefdinir (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": "662007e2-462e-4513-b5b0-efd5dcdc2421", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["CI0FAO63WC"], "rxcui": ["309054", "476576"], "spl_set_id": ["efb5a975-75ec-46e1-ba84-f68d0b9bf36f"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (67877-548-88)", "package_ndc": "67877-548-88", "marketing_start_date": "20210220"}, {"sample": false, "description": "60 mL in 1 BOTTLE (67877-548-98)", "package_ndc": "67877-548-98", "marketing_start_date": "20210220"}], "brand_name": "cefdinir", "product_id": "67877-548_662007e2-462e-4513-b5b0-efd5dcdc2421", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "67877-548", "generic_name": "cefdinir", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cefdinir", "active_ingredients": [{"name": "CEFDINIR", "strength": "250 mg/5mL"}], "application_number": "ANDA210534", "marketing_category": "ANDA", "marketing_start_date": "20210220", "listing_expiration_date": "20261231"}