azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

azithromycin dihydrate 500 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8311
Product ID 68788-8311_45da1013-76ad-4087-b408-6526cd79f235
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
Listing Expiration 2026-12-31
Marketing Start 2022-12-20

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888311
Hyphenated Format 68788-8311

Supplemental Identifiers

RxCUI
248656 749780
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 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 (68788-8311-3) / 3 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

68788-8311-3 1 BLISTER PACK in 1 CARTON (68788-8311-3) / 3 TABLET, FILM COATED in 1 BLISTER PACK

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": "45da1013-76ad-4087-b408-6526cd79f235", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["4e3ca491-2729-4250-8475-f2c9be6ba86e"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (68788-8311-3)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68788-8311-3", "marketing_start_date": "20221220"}], "brand_name": "Azithromycin Dihydrate", "product_id": "68788-8311_45da1013-76ad-4087-b408-6526cd79f235", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "68788-8311", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Preferred Pharmaceuticals 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_start_date": "20221220", "listing_expiration_date": "20261231"}