azithromycin monohydrate

Generic: azithromycin monohydrate

Labeler: sun pharmaceutical industries limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin monohydrate 500 mg/10mL

Manufacturer
Sun Pharmaceutical Industries Limited

Identifiers & Regulatory

Product NDC 70095-025
Product ID 70095-025_dd9fbcb9-f8e5-417f-98b0-6ba9939982c1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065501
Listing Expiration 2026-12-31
Marketing Start 2023-03-27

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70095025
Hyphenated Format 70095-025

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 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 (70095-025-02) / 10 mL in 1 VIAL (70095-025-01)
source: ndc

Packages (1)

70095-025-02 10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01)

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": "dd9fbcb9-f8e5-417f-98b0-6ba9939982c1", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["c8d012c4-f411-4484-a618-7597599ea621"], "manufacturer_name": ["Sun Pharmaceutical Industries Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (70095-025-02)  / 10 mL in 1 VIAL (70095-025-01)", "package_ndc": "70095-025-02", "marketing_start_date": "20230327"}], "brand_name": "Azithromycin monohydrate", "product_id": "70095-025_dd9fbcb9-f8e5-417f-98b0-6ba9939982c1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70095-025", "generic_name": "Azithromycin monohydrate", "labeler_name": "Sun Pharmaceutical Industries 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": "20230327", "listing_expiration_date": "20261231"}