ceftriaxone

Generic: ceftriaxone

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ceftriaxone
Generic Name ceftriaxone
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ceftriaxone sodium 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-346
Product ID 63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065329
Listing Expiration 2026-12-31
Marketing Start 2011-06-20

Pharmacologic Class

Classes
cephalosporin antibacterial [epc] cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323346
Hyphenated Format 63323-346

Supplemental Identifiers

RxCUI
1665005 1665021 1665046
UPC
0363323346010 0363323347017
UNII
023Z5BR09K

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 ceftriaxone (source: ndc)
Generic Name ceftriaxone (source: ndc)
Application Number ANDA065329 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (63323-346-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01)
source: ndc

Packages (1)

63323-346-10 25 VIAL in 1 CARTON (63323-346-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01)

Ingredients (1)

ceftriaxone sodium (1 g/1)

Linked Drug Pages (1)

Ceftriaxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "27777645-c5ae-4c89-abaf-ddb62dc7b859", "openfda": {"upc": ["0363323346010", "0363323347017"], "unii": ["023Z5BR09K"], "rxcui": ["1665005", "1665021", "1665046"], "spl_set_id": ["7ea1db43-40fa-417b-8911-ae98092070a0"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (63323-346-10)  / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (63323-346-01)", "package_ndc": "63323-346-10", "marketing_start_date": "20110620"}], "brand_name": "Ceftriaxone", "product_id": "63323-346_27777645-c5ae-4c89-abaf-ddb62dc7b859", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Cephalosporin Antibacterial [EPC]", "Cephalosporins [CS]"], "product_ndc": "63323-346", "generic_name": "Ceftriaxone", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ceftriaxone", "active_ingredients": [{"name": "CEFTRIAXONE SODIUM", "strength": "1 g/1"}], "application_number": "ANDA065329", "marketing_category": "ANDA", "marketing_start_date": "20110620", "listing_expiration_date": "20261231"}