azithromycin

Generic: azithromycin

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler avkare
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-083
Product ID 42291-083_485b7203-4a64-fbdc-e063-6294a90ac246
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210001
Listing Expiration 2027-12-31
Marketing Start 2022-04-11

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291083
Hyphenated Format 42291-083

Supplemental Identifiers

RxCUI
248656 308460
UPC
0342291083035
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 ANDA210001 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03)
  • 30 TABLET, FILM COATED in 1 BOTTLE (42291-083-30)
source: ndc

Packages (2)

42291-083-03 3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03) 42291-083-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-083-30)

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": "485b7203-4a64-fbdc-e063-6294a90ac246", "openfda": {"upc": ["0342291083035"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "308460"], "spl_set_id": ["dc633b7d-5154-7e43-e053-2a95a90ad2a6"], "manufacturer_name": ["AvKARE"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (42291-083-03)", "package_ndc": "42291-083-03", "marketing_start_date": "20220411"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (42291-083-30)", "package_ndc": "42291-083-30", "marketing_start_date": "20220411"}], "brand_name": "Azithromycin", "product_id": "42291-083_485b7203-4a64-fbdc-e063-6294a90ac246", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "42291-083", "generic_name": "Azithromycin", "labeler_name": "AvKARE", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA210001", "marketing_category": "ANDA", "marketing_start_date": "20220411", "listing_expiration_date": "20271231"}