azithromycin

Generic: azithromycin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 250 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-641
Product ID 65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207370
Listing Expiration 2026-12-31
Marketing Start 2018-07-05

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862641
Hyphenated Format 65862-641

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
UPC
0365862642301
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 (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA207370 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-641-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (65862-641-50)
  • 3 BLISTER PACK in 1 CARTON (65862-641-63) / 6 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (65862-641-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (6)

65862-641-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01) 65862-641-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05) 65862-641-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-641-30) 65862-641-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-641-50) 65862-641-63 3 BLISTER PACK in 1 CARTON (65862-641-63) / 6 TABLET, FILM COATED in 1 BLISTER PACK 65862-641-69 1 BLISTER PACK in 1 CARTON (65862-641-69) / 6 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

azithromycin dihydrate (250 mg/1)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "973a74b9-c813-4af7-b9e8-eb1902c0658a", "openfda": {"upc": ["0365862642301"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["795c13cd-e9ca-481b-9fa9-2890bdf9dac8"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-641-01)", "package_ndc": "65862-641-01", "marketing_start_date": "20180705"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-641-05)", "package_ndc": "65862-641-05", "marketing_start_date": "20180705"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-641-30)", "package_ndc": "65862-641-30", "marketing_start_date": "20180705"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (65862-641-50)", "package_ndc": "65862-641-50", "marketing_start_date": "20180705"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-641-63)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-641-63", "marketing_start_date": "20180705"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65862-641-69)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-641-69", "marketing_start_date": "20180705"}], "brand_name": "Azithromycin", "product_id": "65862-641_973a74b9-c813-4af7-b9e8-eb1902c0658a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "65862-641", "generic_name": "Azithromycin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA207370", "marketing_category": "ANDA", "marketing_start_date": "20180705", "listing_expiration_date": "20261231"}