cephalexin

Generic: cephalexin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cephalexin
Generic Name cephalexin
Labeler preferred pharmaceuticals inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cephalexin 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8538
Product ID 68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065253
Listing Expiration 2026-12-31
Marketing Start 2023-10-19

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888538
Hyphenated Format 68788-8538

Supplemental Identifiers

RxCUI
309114
UNII
OBN7UDS42Y

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
  • 500 mg/1
source: ndc
Packaging
  • 12 CAPSULE in 1 BOTTLE (68788-8538-1)
  • 20 CAPSULE in 1 BOTTLE (68788-8538-2)
  • 30 CAPSULE in 1 BOTTLE (68788-8538-3)
  • 40 CAPSULE in 1 BOTTLE (68788-8538-4)
  • 6 CAPSULE in 1 BOTTLE (68788-8538-5)
  • 60 CAPSULE in 1 BOTTLE (68788-8538-6)
  • 21 CAPSULE in 1 BOTTLE (68788-8538-7)
  • 28 CAPSULE in 1 BOTTLE (68788-8538-8)
  • 14 CAPSULE in 1 BOTTLE (68788-8538-9)
source: ndc

Packages (9)

68788-8538-1 12 CAPSULE in 1 BOTTLE (68788-8538-1) 68788-8538-2 20 CAPSULE in 1 BOTTLE (68788-8538-2) 68788-8538-3 30 CAPSULE in 1 BOTTLE (68788-8538-3) 68788-8538-4 40 CAPSULE in 1 BOTTLE (68788-8538-4) 68788-8538-5 6 CAPSULE in 1 BOTTLE (68788-8538-5) 68788-8538-6 60 CAPSULE in 1 BOTTLE (68788-8538-6) 68788-8538-7 21 CAPSULE in 1 BOTTLE (68788-8538-7) 68788-8538-8 28 CAPSULE in 1 BOTTLE (68788-8538-8) 68788-8538-9 14 CAPSULE in 1 BOTTLE (68788-8538-9)

Ingredients (1)

cephalexin (500 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": "57af31b9-9f8b-4f44-b18d-e59aff4a0bc9", "openfda": {"unii": ["OBN7UDS42Y"], "rxcui": ["309114"], "spl_set_id": ["52d8a080-eafc-46fe-82d9-6b69c6a3a38a"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 CAPSULE in 1 BOTTLE (68788-8538-1)", "package_ndc": "68788-8538-1", "marketing_start_date": "20231019"}, {"sample": false, "description": "20 CAPSULE in 1 BOTTLE (68788-8538-2)", "package_ndc": "68788-8538-2", "marketing_start_date": "20231019"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (68788-8538-3)", "package_ndc": "68788-8538-3", "marketing_start_date": "20231019"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE (68788-8538-4)", "package_ndc": "68788-8538-4", "marketing_start_date": "20231019"}, {"sample": false, "description": "6 CAPSULE in 1 BOTTLE (68788-8538-5)", "package_ndc": "68788-8538-5", "marketing_start_date": "20231019"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (68788-8538-6)", "package_ndc": "68788-8538-6", "marketing_start_date": "20231019"}, {"sample": false, "description": "21 CAPSULE in 1 BOTTLE (68788-8538-7)", "package_ndc": "68788-8538-7", "marketing_start_date": "20231019"}, {"sample": false, "description": "28 CAPSULE in 1 BOTTLE (68788-8538-8)", "package_ndc": "68788-8538-8", "marketing_start_date": "20231019"}, {"sample": false, "description": "14 CAPSULE in 1 BOTTLE (68788-8538-9)", "package_ndc": "68788-8538-9", "marketing_start_date": "20231019"}], "brand_name": "Cephalexin", "product_id": "68788-8538_57af31b9-9f8b-4f44-b18d-e59aff4a0bc9", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68788-8538", "generic_name": "Cephalexin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cephalexin", "active_ingredients": [{"name": "CEPHALEXIN", "strength": "500 mg/1"}], "application_number": "ANDA065253", "marketing_category": "ANDA", "marketing_start_date": "20231019", "listing_expiration_date": "20261231"}