azithromycin

Generic: azithromycin

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-015
Product ID 72189-015_2c4e8f12-2481-4a0d-e063-6394a90a58c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207398
Listing Expiration 2026-12-31
Marketing Start 2019-07-24

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189015
Hyphenated Format 72189-015

Supplemental Identifiers

RxCUI
248656
UNII
5FD1131I7S

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 ANDA207398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (72189-015-02)
  • 3 TABLET, FILM COATED in 1 BOTTLE (72189-015-03)
source: ndc

Packages (2)

72189-015-02 2 TABLET, FILM COATED in 1 BOTTLE (72189-015-02) 72189-015-03 3 TABLET, FILM COATED in 1 BOTTLE (72189-015-03)

Ingredients (1)

azithromycin dihydrate (500 mg/1)

Linked Drug Pages (1)

AZITHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2c4e8f12-2481-4a0d-e063-6394a90a58c5", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (72189-015-02)", "package_ndc": "72189-015-02", "marketing_start_date": "20190724"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (72189-015-03)", "package_ndc": "72189-015-03", "marketing_start_date": "20190724"}], "brand_name": "AZITHROMYCIN", "product_id": "72189-015_2c4e8f12-2481-4a0d-e063-6394a90a58c5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "72189-015", "generic_name": "AZITHROMYCIN", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZITHROMYCIN", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA207398", "marketing_category": "ANDA", "marketing_start_date": "20190724", "listing_expiration_date": "20261231"}