azithromycin

Generic: azithromycin

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin monohydrate 500 mg/5mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-512
Product ID 62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090923
Listing Expiration 2026-12-31
Marketing Start 2020-07-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756512
Hyphenated Format 62756-512

Supplemental Identifiers

RxCUI
1668238
UPC
0362756512405
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 ANDA090923 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (62756-512-44) / 5 mL in 1 VIAL (62756-512-40)
source: ndc

Packages (1)

62756-512-44 10 VIAL in 1 PACKAGE (62756-512-44) / 5 mL in 1 VIAL (62756-512-40)

Ingredients (1)

azithromycin monohydrate (500 mg/5mL)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "822e078d-ea93-4a4b-b640-2cc7174f5b52", "openfda": {"upc": ["0362756512405"], "unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["6a22beb6-57e8-480d-97b5-44d9dbfabf93"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (62756-512-44)  / 5 mL in 1 VIAL (62756-512-40)", "package_ndc": "62756-512-44", "marketing_start_date": "20200715"}], "brand_name": "Azithromycin", "product_id": "62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "62756-512", "generic_name": "Azithromycin", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/5mL"}], "application_number": "ANDA090923", "marketing_category": "ANDA", "marketing_start_date": "20200715", "listing_expiration_date": "20261231"}