azithromycin dihydrate

Generic: azithromycin dihydrate

Labeler: REMEDYREPACK INC.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name azithromycin dihydrate
Generic Name azithromycin dihydrate
Labeler REMEDYREPACK INC.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

AZITHROMYCIN DIHYDRATE 500 mg/1

Identifiers & Regulatory

Product NDC 70518-3723
Product ID 70518-3723_37c3f70d-0dd3-f2ba-e063-6294a90a301a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065399
Marketing Start 2023-04-25
Marketing End 2026-06-30

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183723
Hyphenated Format 70518-3723

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 ANDA065399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3723-2)
source: ndc

Packages (1)

70518-3723-2 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3723-2)

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": "37c3f70d-0dd3-f2ba-e063-6294a90a301a", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["b70fe56d-48c4-48ed-a40d-0ffcbd17b355"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3723-2)", "package_ndc": "70518-3723-2", "marketing_end_date": "20260630", "marketing_start_date": "20240219"}], "brand_name": "azithromycin dihydrate", "product_id": "70518-3723_37c3f70d-0dd3-f2ba-e063-6294a90a301a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70518-3723", "generic_name": "azithromycin dihydrate", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin dihydrate", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065399", "marketing_category": "ANDA", "marketing_end_date": "20260630", "marketing_start_date": "20230425"}