azithromycin

Generic: azithromycin

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler lannett company, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

azithromycin dihydrate 500 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-2395
Product ID 0527-2395_371e26cf-af95-77d5-e063-6294a90a34b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209044
Listing Expiration 2026-12-31
Marketing Start 2019-07-04

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05272395
Hyphenated Format 0527-2395

Supplemental Identifiers

RxCUI
248656 308460 749780 749783
UPC
0305272370203
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 ANDA209044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (0527-2395-19) / 3 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32)
source: ndc

Packages (2)

0527-2395-19 1 BLISTER PACK in 1 CARTON (0527-2395-19) / 3 TABLET, FILM COATED in 1 BLISTER PACK 0527-2395-32 30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32)

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": "371e26cf-af95-77d5-e063-6294a90a34b5", "openfda": {"upc": ["0305272370203"], "unii": ["5FD1131I7S"], "rxcui": ["248656", "308460", "749780", "749783"], "spl_set_id": ["a2b0c06b-e93d-f5aa-e053-2995a90ac9aa"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (0527-2395-19)  / 3 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0527-2395-19", "marketing_start_date": "20190704"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0527-2395-32)", "package_ndc": "0527-2395-32", "marketing_start_date": "20190704"}], "brand_name": "azithromycin", "product_id": "0527-2395_371e26cf-af95-77d5-e063-6294a90a34b5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "0527-2395", "generic_name": "AZITHROMYCIN", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/1"}], "application_number": "ANDA209044", "marketing_category": "ANDA", "marketing_start_date": "20190704", "listing_expiration_date": "20261231"}