azithromycin

Generic: azithromycin monohydrate

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

Drug Facts

Product Profile

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

azithromycin monohydrate 500 mg/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-398
Product ID 63323-398_2143a7d1-6575-4d24-8ef4-001ecf2671e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065179
Listing Expiration 2026-12-31
Marketing Start 2006-03-20

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323398
Hyphenated Format 63323-398

Supplemental Identifiers

RxCUI
1668238
UPC
0363323398019
UNII
JTE4MNN1MD

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 azithromycin (source: ndc)
Generic Name azithromycin monohydrate (source: ndc)
Application Number ANDA065179 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-398-10) / 5 mL in 1 VIAL (63323-398-01)
source: ndc

Packages (1)

63323-398-10 10 VIAL in 1 TRAY (63323-398-10) / 5 mL in 1 VIAL (63323-398-01)

Ingredients (1)

azithromycin monohydrate (500 mg/5mL)

Linked Drug Pages (3)

Azithromycin ndc-match (0.9) Azithromycin ndc-match (0.9) Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2143a7d1-6575-4d24-8ef4-001ecf2671e2", "openfda": {"upc": ["0363323398019"], "unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["b69917c0-95d5-4b29-b0e3-07054a4fd79f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-398-10)  / 5 mL in 1 VIAL (63323-398-01)", "package_ndc": "63323-398-10", "marketing_start_date": "20060320"}], "brand_name": "Azithromycin", "product_id": "63323-398_2143a7d1-6575-4d24-8ef4-001ecf2671e2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "63323-398", "generic_name": "AZITHROMYCIN MONOHYDRATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/5mL"}], "application_number": "ANDA065179", "marketing_category": "ANDA", "marketing_start_date": "20060320", "listing_expiration_date": "20261231"}