azasite

Generic: azithromycin monohydrate

Labeler: thea pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name azasite
Generic Name azithromycin monohydrate
Labeler thea pharma inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

azithromycin monohydrate 10 mg/mL

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-307
Product ID 82584-307_1e292167-581f-b1db-e063-6394a90ae8a1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050810
Listing Expiration 2026-12-31
Marketing Start 2022-11-01

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82584307
Hyphenated Format 82584-307

Supplemental Identifiers

RxCUI
706868 706872
UNII
JTE4MNN1MD

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 azasite (source: ndc)
Generic Name azithromycin monohydrate (source: ndc)
Application Number NDA050810 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82584-307-02 1 BOTTLE, DROPPER in 1 CARTON (82584-307-02) / 2.5 mL in 1 BOTTLE, DROPPER 82584-307-03 1 BOTTLE, DROPPER in 1 CARTON (82584-307-03) / 2.5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

azithromycin monohydrate (10 mg/mL)

Linked Drug Pages (1)

AZASITE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1e292167-581f-b1db-e063-6394a90ae8a1", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["706868", "706872"], "spl_set_id": ["0c5d6f5e-18ea-436f-8c62-bbaf66effe3d"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE, DROPPER in 1 CARTON (82584-307-02)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82584-307-02", "marketing_start_date": "20221101"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82584-307-03)  / 2.5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82584-307-03", "marketing_start_date": "20221101"}], "brand_name": "AZASITE", "product_id": "82584-307_1e292167-581f-b1db-e063-6394a90ae8a1", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "82584-307", "generic_name": "azithromycin monohydrate", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZASITE", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "10 mg/mL"}], "application_number": "NDA050810", "marketing_category": "NDA", "marketing_start_date": "20221101", "listing_expiration_date": "20261231"}