cephalexin

Generic: cephalexin

Labeler: cronus pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cephalexin
Generic Name cephalexin
Labeler cronus pharma llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cephalexin 250 mg/1

Manufacturer
Cronus Pharma LLC

Identifiers & Regulatory

Product NDC 69043-008
Product ID 69043-008_c71c6d65-8fdd-496e-9338-c70276699886
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065253
Listing Expiration 2026-12-31
Marketing Start 2005-11-16

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69043008
Hyphenated Format 69043-008

Supplemental Identifiers

RxCUI
309112 309114
UPC
0369043008016 0369043009013
UNII
OBN7UDS42Y

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 cephalexin (source: ndc)
Generic Name cephalexin (source: ndc)
Application Number ANDA065253 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (69043-008-01)
  • 500 CAPSULE in 1 BOTTLE (69043-008-05)
source: ndc

Packages (2)

69043-008-01 100 CAPSULE in 1 BOTTLE (69043-008-01) 69043-008-05 500 CAPSULE in 1 BOTTLE (69043-008-05)

Ingredients (1)

cephalexin (250 mg/1)

Linked Drug Pages (1)

Cephalexin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c71c6d65-8fdd-496e-9338-c70276699886", "openfda": {"upc": ["0369043008016", "0369043009013"], "unii": ["OBN7UDS42Y"], "rxcui": ["309112", "309114"], "spl_set_id": ["a4e861e2-5803-4c4a-a962-92f5755e1ab5"], "manufacturer_name": ["Cronus Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (69043-008-01)", "package_ndc": "69043-008-01", "marketing_start_date": "20051116"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (69043-008-05)", "package_ndc": "69043-008-05", "marketing_start_date": "20051116"}], "brand_name": "Cephalexin", "product_id": "69043-008_c71c6d65-8fdd-496e-9338-c70276699886", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "69043-008", "generic_name": "Cephalexin", "labeler_name": "Cronus Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cephalexin", "active_ingredients": [{"name": "CEPHALEXIN", "strength": "250 mg/1"}], "application_number": "ANDA065253", "marketing_category": "ANDA", "marketing_start_date": "20051116", "listing_expiration_date": "20261231"}