cephalexin

Generic: cephalexin

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

Drug Facts

Product Profile

Brand Name cephalexin
Generic Name cephalexin
Labeler lupin pharmaceuticals, inc.
Dosage Form FOR SUSPENSION
Routes
ORAL
Active Ingredients

cephalexin 125 mg/5mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-440
Product ID 68180-440_0aa83725-d24d-42d6-afd0-c9b2f982b873
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065234
Listing Expiration 2026-12-31
Marketing Start 2017-08-21

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68180440
Hyphenated Format 68180-440

Supplemental Identifiers

RxCUI
309110 309113
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 ANDA065234 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (68180-440-01)
  • 200 mL in 1 BOTTLE (68180-440-02)
source: ndc

Packages (2)

68180-440-01 100 mL in 1 BOTTLE (68180-440-01) 68180-440-02 200 mL in 1 BOTTLE (68180-440-02)

Ingredients (1)

cephalexin (125 mg/5mL)

Linked Drug Pages (1)

cephalexin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0aa83725-d24d-42d6-afd0-c9b2f982b873", "openfda": {"unii": ["OBN7UDS42Y"], "rxcui": ["309110", "309113"], "spl_set_id": ["25ef498a-7a7e-4543-a544-b9d0e99f9cd9"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (68180-440-01)", "package_ndc": "68180-440-01", "marketing_start_date": "20170821"}, {"sample": false, "description": "200 mL in 1 BOTTLE (68180-440-02)", "package_ndc": "68180-440-02", "marketing_start_date": "20170906"}], "brand_name": "cephalexin", "product_id": "68180-440_0aa83725-d24d-42d6-afd0-c9b2f982b873", "dosage_form": "FOR SUSPENSION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "68180-440", "generic_name": "Cephalexin", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "cephalexin", "active_ingredients": [{"name": "CEPHALEXIN", "strength": "125 mg/5mL"}], "application_number": "ANDA065234", "marketing_category": "ANDA", "marketing_start_date": "20170821", "listing_expiration_date": "20261231"}