azithromycin monohydrate

Generic: azithromycin monohydrate

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin monohydrate
Generic Name azithromycin monohydrate
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin monohydrate 500 mg/10mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-199
Product ID 68083-199_d0a507c6-cb4b-4295-bf17-48bb8e4b03f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065501
Listing Expiration 2026-12-31
Marketing Start 2009-11-09

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083199
Hyphenated Format 68083-199

Supplemental Identifiers

RxCUI
1668238
UPC
0368083199104
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 monohydrate (source: ndc)
Generic Name azithromycin monohydrate (source: ndc)
Application Number ANDA065501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/10mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-199-10 10 VIAL in 1 CARTON (68083-199-10) / 10 mL in 1 VIAL

Ingredients (1)

azithromycin monohydrate (500 mg/10mL)

Linked Drug Pages (1)

Azithromycin monohydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d0a507c6-cb4b-4295-bf17-48bb8e4b03f3", "openfda": {"upc": ["0368083199104"], "unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["55051e03-b6dc-4bc6-87c1-e4fb84b61fa3"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-199-10)  / 10 mL in 1 VIAL", "package_ndc": "68083-199-10", "marketing_start_date": "20091109"}], "brand_name": "Azithromycin monohydrate", "product_id": "68083-199_d0a507c6-cb4b-4295-bf17-48bb8e4b03f3", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68083-199", "generic_name": "Azithromycin monohydrate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin monohydrate", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/10mL"}], "application_number": "ANDA065501", "marketing_category": "ANDA", "marketing_start_date": "20091109", "listing_expiration_date": "20261231"}