azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: precision dose, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 250 mg/1

Manufacturer
Precision Dose, Inc.

Identifiers & Regulatory

Product NDC 68094-900
Product ID 68094-900_13f26d0c-64ea-479d-b97e-46e4f01feb37
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094900
Hyphenated Format 68094-900

Supplemental Identifiers

RxCUI
308460 749783
UPC
0368094900508
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 ANDA208250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (68094-900-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 3 CARTON in 1 BOX (68094-900-18) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68094-900-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (68094-900-50)
source: ndc

Packages (4)

68094-900-06 1 BLISTER PACK in 1 CARTON (68094-900-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK 68094-900-18 3 CARTON in 1 BOX (68094-900-18) / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK 68094-900-30 30 TABLET, FILM COATED in 1 BOTTLE (68094-900-30) 68094-900-50 100 TABLET, FILM COATED in 1 BOTTLE (68094-900-50)

Ingredients (1)

azithromycin dihydrate (250 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": "13f26d0c-64ea-479d-b97e-46e4f01feb37", "openfda": {"upc": ["0368094900508"], "unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["d9b66736-3f1a-4d6d-bdc4-274f5adfb40c"], "manufacturer_name": ["Precision Dose, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68094-900-06)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68094-900-06", "marketing_start_date": "20240215"}, {"sample": false, "description": "3 CARTON in 1 BOX (68094-900-18)  / 1 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68094-900-18", "marketing_start_date": "20240215"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68094-900-30)", "package_ndc": "68094-900-30", "marketing_start_date": "20240215"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68094-900-50)", "package_ndc": "68094-900-50", "marketing_start_date": "20240215"}], "brand_name": "Azithromycin Dihydrate", "product_id": "68094-900_13f26d0c-64ea-479d-b97e-46e4f01feb37", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68094-900", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Precision Dose, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin Dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA208250", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}