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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 200 mg/5mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-093
Product ID 63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065246
Listing Expiration 2026-12-31
Marketing Start 2010-12-17

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187093
Hyphenated Format 63187-093

Supplemental Identifiers

RxCUI
141963
UPC
0363187093150
UNII
JTE4MNN1MD

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 ANDA065246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE (63187-093-15)
  • 22.5 mL in 1 BOTTLE (63187-093-22)
  • 30 mL in 1 BOTTLE (63187-093-30)
source: ndc

Packages (3)

63187-093-15 15 mL in 1 BOTTLE (63187-093-15) 63187-093-22 22.5 mL in 1 BOTTLE (63187-093-22) 63187-093-30 30 mL in 1 BOTTLE (63187-093-30)

Ingredients (1)

azithromycin monohydrate (200 mg/5mL)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9d10dacc-ad17-48ec-b037-94987b2c40bc", "openfda": {"upc": ["0363187093150"], "unii": ["JTE4MNN1MD"], "rxcui": ["141963"], "spl_set_id": ["44134421-cb0b-4e85-a3c8-d58bdb476fad"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE (63187-093-15)", "package_ndc": "63187-093-15", "marketing_start_date": "20140701"}, {"sample": false, "description": "22.5 mL in 1 BOTTLE (63187-093-22)", "package_ndc": "63187-093-22", "marketing_start_date": "20240403"}, {"sample": false, "description": "30 mL in 1 BOTTLE (63187-093-30)", "package_ndc": "63187-093-30", "marketing_start_date": "20140701"}], "brand_name": "Azithromycin", "product_id": "63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "63187-093", "generic_name": "Azithromycin", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA065246", "marketing_category": "ANDA", "marketing_start_date": "20101217", "listing_expiration_date": "20261231"}