azithromycin dihydrate

Generic: azithromycin dihydrate

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

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 250 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4160
Product ID 70518-4160_49d7bf04-15e5-a936-e063-6394a90a12b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208250
Listing Expiration 2027-12-31
Marketing Start 2024-08-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705184160
Hyphenated Format 70518-4160

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2)
  • 1 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)
source: ndc

Packages (6)

70518-4160-0 6 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0) 70518-4160-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1) 70518-4160-2 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2) 70518-4160-3 1 BLISTER PACK in 1 CARTON (70518-4160-3) / 6 TABLET, FILM COATED in 1 BLISTER PACK 70518-4160-4 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4) 70518-4160-5 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)

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": "49d7bf04-15e5-a936-e063-6394a90a12b3", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["f0cfda1a-910f-4764-8658-263037df5ea8"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-0)", "package_ndc": "70518-4160-0", "marketing_start_date": "20240815"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4160-1)", "package_ndc": "70518-4160-1", "marketing_start_date": "20240828"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-2)", "package_ndc": "70518-4160-2", "marketing_start_date": "20240923"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (70518-4160-3)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "70518-4160-3", "marketing_start_date": "20250402"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-4)", "package_ndc": "70518-4160-4", "marketing_start_date": "20250913"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4160-5)", "package_ndc": "70518-4160-5", "marketing_start_date": "20260201"}], "brand_name": "Azithromycin Dihydrate", "product_id": "70518-4160_49d7bf04-15e5-a936-e063-6394a90a12b3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70518-4160", "generic_name": "Azithromycin Dihydrate", "labeler_name": "REMEDYREPACK 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": "20240815", "listing_expiration_date": "20271231"}