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 dihydrate 500 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-674
Product ID 71205-674_69477c94-fdae-4d10-b4e0-2f3c566f2eba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065212
Listing Expiration 2026-12-31
Marketing Start 2005-11-14

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205674
Hyphenated Format 71205-674

Supplemental Identifiers

RxCUI
248656 749780
UPC
0371205674038
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 (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA065212 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 DOSE PACK in 1 CARTON (71205-674-03) / 3 TABLET, FILM COATED in 1 DOSE PACK
source: ndc

Packages (1)

71205-674-03 1 DOSE PACK in 1 CARTON (71205-674-03) / 3 TABLET, FILM COATED in 1 DOSE PACK

Ingredients (1)

azithromycin dihydrate (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": "69477c94-fdae-4d10-b4e0-2f3c566f2eba", "openfda": {"upc": ["0371205674038"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "749780"], "spl_set_id": ["90605f94-93e1-43d1-8be7-830e816ac84f"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 DOSE PACK in 1 CARTON (71205-674-03)  / 3 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "71205-674-03", "marketing_start_date": "20220707"}], "brand_name": "Azithromycin", "product_id": "71205-674_69477c94-fdae-4d10-b4e0-2f3c566f2eba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "71205-674", "generic_name": "Azithromycin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA065212", "marketing_category": "ANDA", "marketing_start_date": "20051114", "listing_expiration_date": "20261231"}