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 72189-088
Product ID 72189-088_26f851bf-1b84-d000-e063-6394a90a079c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210001
Listing Expiration 2026-12-31
Marketing Start 2020-06-18

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189088
Hyphenated Format 72189-088

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
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 ANDA210001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE (72189-088-02)
  • 3 TABLET, FILM COATED in 1 BOTTLE (72189-088-03)
source: ndc

Packages (2)

72189-088-02 2 TABLET, FILM COATED in 1 BOTTLE (72189-088-02) 72189-088-03 3 TABLET, FILM COATED in 1 BOTTLE (72189-088-03)

Ingredients (1)

azithromycin dihydrate (500 mg/1)

Linked Drug Pages (1)

AZITHROMYCIN, AZITHROMYCIN DIHYDRATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "26f851bf-1b84-d000-e063-6394a90a079c", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["a5b4092d-ab72-f5d1-e053-2995a90ac582"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (72189-088-02)", "package_ndc": "72189-088-02", "marketing_start_date": "20200618"}, {"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (72189-088-03)", "package_ndc": "72189-088-03", "marketing_start_date": "20200618"}], "brand_name": "AZITHROMYCIN", "product_id": "72189-088_26f851bf-1b84-d000-e063-6394a90a079c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "72189-088", "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": "ANDA210001", "marketing_category": "ANDA", "marketing_start_date": "20200618", "listing_expiration_date": "20261231"}