azithromycin

Generic: azithromycin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler eugia us llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin monohydrate 500 mg/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-174
Product ID 55150-174_6760771b-9c61-458d-9778-81a3da96cb9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203294
Listing Expiration 2026-12-31
Marketing Start 2015-06-19

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150174
Hyphenated Format 55150-174

Supplemental Identifiers

RxCUI
1668238
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 (source: ndc)
Application Number ANDA203294 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-174-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

azithromycin monohydrate (500 mg/1)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6760771b-9c61-458d-9778-81a3da96cb9f", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["7b81436e-d14a-4353-a22d-253f45e2e576"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-174-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-174-10", "marketing_start_date": "20150619"}], "brand_name": "Azithromycin", "product_id": "55150-174_6760771b-9c61-458d-9778-81a3da96cb9f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "55150-174", "generic_name": "Azithromycin", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA203294", "marketing_category": "ANDA", "marketing_start_date": "20150619", "listing_expiration_date": "20261231"}