azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: tagi pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler tagi pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
TAGI Pharma, Inc.

Identifiers & Regulatory

Product NDC 51224-122
Product ID 51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
Marketing Start 2019-07-01
Marketing End 2026-10-31

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51224122
Hyphenated Format 51224-122

Supplemental Identifiers

RxCUI
248656 749780
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 dihydrate (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number ANDA208249 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 CARTON in 1 BOX (51224-122-09) / 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (51224-122-30)
source: ndc

Packages (3)

51224-122-03 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 51224-122-09 3 CARTON in 1 BOX (51224-122-09) / 1 BLISTER PACK in 1 CARTON (51224-122-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 51224-122-30 30 TABLET, FILM COATED in 1 BOTTLE (51224-122-30)

Ingredients (1)

azithromycin dihydrate (500 mg/1)

Linked Drug Pages (1)

Azithromycin Dihydrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["41e2163b-af61-4323-8b9c-2d44fc122fd9"], "manufacturer_name": ["TAGI Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51224-122-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51224-122-03", "marketing_end_date": "20260531", "marketing_start_date": "20190701"}, {"sample": false, "description": "3 CARTON in 1 BOX (51224-122-09)  / 1 BLISTER PACK in 1 CARTON (51224-122-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "51224-122-09", "marketing_end_date": "20261031", "marketing_start_date": "20190701"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51224-122-30)", "package_ndc": "51224-122-30", "marketing_end_date": "20261031", "marketing_start_date": "20190701"}], "brand_name": "Azithromycin Dihydrate", "product_id": "51224-122_4e2d2728-b3ae-4a85-8c2a-5e74c60a0f6b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "51224-122", "generic_name": "Azithromycin Dihydrate", "labeler_name": "TAGI Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA208249", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20190701"}