aztreonam

Generic: aztreonam

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

Drug Facts

Product Profile

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

aztreonam 1 g/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-401
Product ID 63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065439
Listing Expiration 2026-12-31
Marketing Start 2009-11-05

Pharmacologic Class

Established (EPC)
monobactam antibacterial [epc]
Chemical Structure
monobactams [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323401
Hyphenated Format 63323-401

Supplemental Identifiers

RxCUI
1664981 1664986
UPC
0363323401016 0363323402013
UNII
G2B4VE5GH8
NUI
N0000175493 M0014030

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 aztreonam (source: ndc)
Generic Name aztreonam (source: ndc)
Application Number ANDA065439 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)
source: ndc

Packages (1)

63323-401-20 10 VIAL in 1 TRAY (63323-401-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)

Ingredients (1)

aztreonam (1 g/1)

Linked Drug Pages (3)

Aztreonam ndc-match (0.9) Aztreonam ndc-match (0.9) Aztreonam ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "b6926b10-085f-4255-b4f1-24572a7ef57a", "openfda": {"nui": ["N0000175493", "M0014030"], "upc": ["0363323401016", "0363323402013"], "unii": ["G2B4VE5GH8"], "rxcui": ["1664981", "1664986"], "spl_set_id": ["c6cf7e13-a04e-47e2-9cec-44a278ee6bec"], "pharm_class_cs": ["Monobactams [CS]"], "pharm_class_epc": ["Monobactam Antibacterial [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-401-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63323-401-01)", "package_ndc": "63323-401-20", "marketing_start_date": "20091105"}], "brand_name": "Aztreonam", "product_id": "63323-401_b6926b10-085f-4255-b4f1-24572a7ef57a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Monobactam Antibacterial [EPC]", "Monobactams [CS]"], "product_ndc": "63323-401", "generic_name": "AZTREONAM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Aztreonam", "active_ingredients": [{"name": "AZTREONAM", "strength": "1 g/1"}], "application_number": "ANDA065439", "marketing_category": "ANDA", "marketing_start_date": "20091105", "listing_expiration_date": "20261231"}