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 250 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-214
Product ID 82804-214_25bc2e78-9d0d-41c6-a55e-a267d4457967
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065398
Listing Expiration 2026-12-31
Marketing Start 2022-11-17

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804214
Hyphenated Format 82804-214

Supplemental Identifiers

RxCUI
308460 749783
UPC
0382804214068
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 ANDA065398 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 250 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BLISTER PACK (82804-214-06)
source: ndc

Packages (1)

82804-214-06 6 TABLET, FILM COATED in 1 BLISTER PACK (82804-214-06)

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": "25bc2e78-9d0d-41c6-a55e-a267d4457967", "openfda": {"upc": ["0382804214068"], "unii": ["5FD1131I7S"], "rxcui": ["308460", "749783"], "spl_set_id": ["25bc2e78-9d0d-41c6-a55e-a267d4457967"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BLISTER PACK (82804-214-06)", "package_ndc": "82804-214-06", "marketing_start_date": "20250407"}], "brand_name": "azithromycin", "product_id": "82804-214_25bc2e78-9d0d-41c6-a55e-a267d4457967", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "82804-214", "generic_name": "azithromycin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "250 mg/1"}], "application_number": "ANDA065398", "marketing_category": "ANDA", "marketing_start_date": "20221117", "listing_expiration_date": "20261231"}