azithromycin

Generic: azithromycin monohydrate

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin monohydrate
Labeler sagent pharmaceuticals
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin monohydrate 500 mg/5mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-180
Product ID 25021-180_b0e66ff2-e3f0-4c89-9eb9-8122d1020d29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065501
Listing Expiration 2026-12-31
Marketing Start 2024-09-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021180
Hyphenated Format 25021-180

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 monohydrate (source: ndc)
Application Number ANDA065501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-180-66) / 5 mL in 1 VIAL
source: ndc

Packages (1)

25021-180-66 10 VIAL in 1 CARTON (25021-180-66) / 5 mL in 1 VIAL

Ingredients (1)

azithromycin monohydrate (500 mg/5mL)

Linked Drug Pages (2)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b0e66ff2-e3f0-4c89-9eb9-8122d1020d29", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["6497fb5e-82d8-4411-b994-7ee01333ffd7"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-180-66)  / 5 mL in 1 VIAL", "package_ndc": "25021-180-66", "marketing_start_date": "20240915"}], "brand_name": "Azithromycin", "product_id": "25021-180_b0e66ff2-e3f0-4c89-9eb9-8122d1020d29", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "25021-180", "generic_name": "azithromycin monohydrate", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/5mL"}], "application_number": "ANDA065501", "marketing_category": "ANDA", "marketing_start_date": "20240915", "listing_expiration_date": "20261231"}