azithromycin

Generic: azithromycin

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

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler aurobindo pharma limited
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin dihydrate 100 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-007
Product ID 59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209201
Listing Expiration 2026-12-31
Marketing Start 2018-10-09

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651007
Hyphenated Format 59651-007

Supplemental Identifiers

RxCUI
141963 308459
UNII
5FD1131I7S

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 ANDA209201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

59651-007-15 1 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE

Ingredients (1)

azithromycin dihydrate (100 mg/5mL)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2e840f6-e3a8-4524-a36e-2ce70d67cf2a", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["141963", "308459"], "spl_set_id": ["3c902990-b870-4725-b9fe-76b8be633e1c"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-007-15)  / 15 mL in 1 BOTTLE", "package_ndc": "59651-007-15", "marketing_start_date": "20181009"}], "brand_name": "Azithromycin", "product_id": "59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "59651-007", "generic_name": "Azithromycin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "100 mg/5mL"}], "application_number": "ANDA209201", "marketing_category": "ANDA", "marketing_start_date": "20181009", "listing_expiration_date": "20261231"}