ceftriaxone sodium

Generic: ceftriaxone sodium

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

Drug Facts

Product Profile

Brand Name ceftriaxone sodium
Generic Name ceftriaxone sodium
Labeler asclemed usa, inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ceftriaxone sodium 500 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-596
Product ID 76420-596_045b6441-f12b-f2b4-e063-6394a90ad0ac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203702
Listing Expiration 2026-12-31
Marketing Start 2017-06-30

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420596
Hyphenated Format 76420-596

Supplemental Identifiers

RxCUI
1665005
UNII
023Z5BR09K

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 ceftriaxone sodium (source: ndc)
Generic Name ceftriaxone sodium (source: ndc)
Application Number ANDA203702 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (76420-596-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
  • 10 VIAL, SINGLE-USE in 1 CARTON (76420-596-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

76420-596-01 1 VIAL, SINGLE-USE in 1 CARTON (76420-596-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE 76420-596-10 10 VIAL, SINGLE-USE in 1 CARTON (76420-596-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE

Ingredients (1)

ceftriaxone sodium (500 mg/1)

Linked Drug Pages (1)

Ceftriaxone Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "045b6441-f12b-f2b4-e063-6394a90ad0ac", "openfda": {"unii": ["023Z5BR09K"], "rxcui": ["1665005"], "spl_set_id": ["f01cf0e5-caaf-4759-ba21-50f3aceff523"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (76420-596-01)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "76420-596-01", "marketing_start_date": "20230902"}, {"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (76420-596-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE", "package_ndc": "76420-596-10", "marketing_start_date": "20230902"}], "brand_name": "Ceftriaxone Sodium", "product_id": "76420-596_045b6441-f12b-f2b4-e063-6394a90ad0ac", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "76420-596", "generic_name": "Ceftriaxone Sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ceftriaxone Sodium", "active_ingredients": [{"name": "CEFTRIAXONE SODIUM", "strength": "500 mg/1"}], "application_number": "ANDA203702", "marketing_category": "ANDA", "marketing_start_date": "20170630", "listing_expiration_date": "20261231"}