azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: health department, oklahoma state
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler health department, oklahoma state
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Health Department, Oklahoma State

Identifiers & Regulatory

Product NDC 83112-501
Product ID 83112-501_4747c5d8-4832-c725-e063-6394a90a4fda
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208249
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 83112501
Hyphenated Format 83112-501

Supplemental Identifiers

RxCUI
248656
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
  • 2 TABLET, FILM COATED in 1 PACKET (83112-501-00)
  • 2 TABLET, FILM COATED in 1 PACKET (83112-501-02)
  • 4 TABLET, FILM COATED in 1 PACKET (83112-501-04)
source: ndc

Packages (3)

83112-501-00 2 TABLET, FILM COATED in 1 PACKET (83112-501-00) 83112-501-02 2 TABLET, FILM COATED in 1 PACKET (83112-501-02) 83112-501-04 4 TABLET, FILM COATED in 1 PACKET (83112-501-04)

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": "4747c5d8-4832-c725-e063-6394a90a4fda", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656"], "spl_set_id": ["4747c5d8-4831-c725-e063-6394a90a4fda"], "manufacturer_name": ["Health Department, Oklahoma State"]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 PACKET (83112-501-00)", "package_ndc": "83112-501-00", "marketing_start_date": "20240215"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 PACKET (83112-501-02)", "package_ndc": "83112-501-02", "marketing_start_date": "20240215"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 PACKET (83112-501-04)", "package_ndc": "83112-501-04", "marketing_start_date": "20240215"}], "brand_name": "Azithromycin Dihydrate", "product_id": "83112-501_4747c5d8-4832-c725-e063-6394a90a4fda", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "83112-501", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Health Department, Oklahoma State", "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": "20240215", "listing_expiration_date": "20261231"}