azithromycin

Generic: azithromycin

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin monohydrate 250 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 50111-787
Product ID 50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065225
Listing Expiration 2026-12-31
Marketing Start 2006-01-06

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50111787
Hyphenated Format 50111-787

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
UPC
0350111788107 0350111787100
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 (source: ndc)
Application Number ANDA065225 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50111-787-10)
  • 1 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

50111-787-10 30 TABLET, FILM COATED in 1 BOTTLE (50111-787-10) 50111-787-51 1 BLISTER PACK in 1 CARTON (50111-787-51) / 6 TABLET, FILM COATED in 1 BLISTER PACK 50111-787-66 3 CARTON in 1 PACKAGE (50111-787-66) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

azithromycin monohydrate (250 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": "96661456-78d1-48f2-bcd9-ceb3a8437387", "openfda": {"upc": ["0350111788107", "0350111787100"], "unii": ["JTE4MNN1MD"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["f6a52c0b-45db-422e-8c22-e867a11b4439"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50111-787-10)", "package_ndc": "50111-787-10", "marketing_start_date": "20060106"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50111-787-51)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50111-787-51", "marketing_start_date": "20060106"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE (50111-787-66)  / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50111-787-66", "marketing_start_date": "20060106"}], "brand_name": "Azithromycin", "product_id": "50111-787_96661456-78d1-48f2-bcd9-ceb3a8437387", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "50111-787", "generic_name": "Azithromycin", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065225", "marketing_category": "ANDA", "marketing_start_date": "20060106", "listing_expiration_date": "20261231"}