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 CAPSULE
Routes
ORAL
Active Ingredients

cefdinir 300 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-543
Product ID 67877-543_88df7b4a-ada5-4fd3-8e16-48053abdf1b2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210220
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 67877543
Hyphenated Format 67877-543

Supplemental Identifiers

RxCUI
200346
UPC
0367877543604
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 ANDA210220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (67877-543-01)
  • 10 BLISTER PACK in 1 CARTON (67877-543-38) / 10 CAPSULE in 1 BLISTER PACK (67877-543-33)
  • 60 CAPSULE in 1 BOTTLE (67877-543-60)
source: ndc

Packages (3)

67877-543-01 100 CAPSULE in 1 BOTTLE (67877-543-01) 67877-543-38 10 BLISTER PACK in 1 CARTON (67877-543-38) / 10 CAPSULE in 1 BLISTER PACK (67877-543-33) 67877-543-60 60 CAPSULE in 1 BOTTLE (67877-543-60)

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": "88df7b4a-ada5-4fd3-8e16-48053abdf1b2", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0367877543604"], "unii": ["CI0FAO63WC"], "rxcui": ["200346"], "spl_set_id": ["18888955-4db3-4d0d-939f-eaaa5f2e0dc4"], "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 CAPSULE in 1 BOTTLE (67877-543-01)", "package_ndc": "67877-543-01", "marketing_start_date": "20210220"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (67877-543-38)  / 10 CAPSULE in 1 BLISTER PACK (67877-543-33)", "package_ndc": "67877-543-38", "marketing_start_date": "20210220"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (67877-543-60)", "package_ndc": "67877-543-60", "marketing_start_date": "20210220"}], "brand_name": "Cefdinir", "product_id": "67877-543_88df7b4a-ada5-4fd3-8e16-48053abdf1b2", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "67877-543", "generic_name": "Cefdinir", "labeler_name": "Ascend Laboratories, LLC", "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": "20210220", "listing_expiration_date": "20261231"}