cephalexin

Generic: cephalexin

Labeler: asclemed usa, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cephalexin
Generic Name cephalexin
Labeler asclemed usa, inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cephalexin 500 mg/1

Manufacturer
Asclemed USA, Inc

Identifiers & Regulatory

Product NDC 76420-831
Product ID 76420-831_247cf995-f553-60a9-e063-6394a90ad8d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065229
Listing Expiration 2026-12-31
Marketing Start 2023-09-07

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420831
Hyphenated Format 76420-831

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 ANDA065229 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-10)
  • 30 CAPSULE in 1 BLISTER PACK (76420-831-30)
  • 40 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-40)
  • 42 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-42)
source: ndc

Packages (4)

76420-831-10 10 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-10) 76420-831-30 30 CAPSULE in 1 BLISTER PACK (76420-831-30) 76420-831-40 40 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-40) 76420-831-42 42 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-42)

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": "247cf995-f553-60a9-e063-6394a90ad8d1", "openfda": {"unii": ["OBN7UDS42Y"], "rxcui": ["309114"], "spl_set_id": ["945552cb-90e4-41fb-afe2-8ee8785e94da"], "manufacturer_name": ["Asclemed USA, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-10)", "package_ndc": "76420-831-10", "marketing_start_date": "20240717"}, {"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (76420-831-30)", "package_ndc": "76420-831-30", "marketing_start_date": "20240717"}, {"sample": false, "description": "40 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-40)", "package_ndc": "76420-831-40", "marketing_start_date": "20240717"}, {"sample": false, "description": "42 CAPSULE in 1 BOTTLE, PLASTIC (76420-831-42)", "package_ndc": "76420-831-42", "marketing_start_date": "20240717"}], "brand_name": "Cephalexin", "product_id": "76420-831_247cf995-f553-60a9-e063-6394a90ad8d1", "dosage_form": "CAPSULE", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "76420-831", "generic_name": "Cephalexin", "labeler_name": "Asclemed USA, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cephalexin", "active_ingredients": [{"name": "CEPHALEXIN", "strength": "500 mg/1"}], "application_number": "ANDA065229", "marketing_category": "ANDA", "marketing_start_date": "20230907", "listing_expiration_date": "20261231"}