azithromycin

Generic: azithromycin

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin monohydrate 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-189
Product ID 63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065223
Listing Expiration 2026-12-31
Marketing Start 2006-01-06

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187189
Hyphenated Format 63187-189

Supplemental Identifiers

RxCUI
248656 308460 749783
UPC
0363187189037 0363187007041
UNII
JTE4MNN1MD

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 ANDA065223 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BOX (63187-189-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04)
source: ndc

Packages (2)

63187-189-03 1 BLISTER PACK in 1 BOX (63187-189-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK 63187-189-04 4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04)

Ingredients (1)

azithromycin monohydrate (500 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": "d6250595-3500-4c6f-8175-25a8a92e2d5e", "openfda": {"upc": ["0363187189037", "0363187007041"], "unii": ["JTE4MNN1MD"], "rxcui": ["248656", "308460", "749783"], "spl_set_id": ["7e7c2f49-449c-4ba2-98ae-0ff0c040614c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX (63187-189-03)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "63187-189-03", "marketing_start_date": "20141001"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE (63187-189-04)", "package_ndc": "63187-189-04", "marketing_start_date": "20220914"}], "brand_name": "Azithromycin", "product_id": "63187-189_d6250595-3500-4c6f-8175-25a8a92e2d5e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "63187-189", "generic_name": "Azithromycin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065223", "marketing_category": "ANDA", "marketing_start_date": "20060106", "listing_expiration_date": "20261231"}