azithromycin

Generic: azithromycin

Labeler: directrx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler directrx
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 200 mg/5mL

Manufacturer
DirectRx

Identifiers & Regulatory

Product NDC 72189-314
Product ID 72189-314_2c3cfbf7-a5af-5075-e063-6294a90a04e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207531
Listing Expiration 2026-12-31
Marketing Start 2022-01-12

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189314
Hyphenated Format 72189-314

Supplemental Identifiers

RxCUI
141963
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 ANDA207531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 22.5 mL in 1 BOTTLE (72189-314-22)
source: ndc

Packages (1)

72189-314-22 22.5 mL in 1 BOTTLE (72189-314-22)

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": "2c3cfbf7-a5af-5075-e063-6294a90a04e5", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["141963"], "spl_set_id": ["d564d91e-3039-c120-e053-2995a90ae6db"], "manufacturer_name": ["DirectRx"]}, "finished": true, "packaging": [{"sample": false, "description": "22.5 mL in 1 BOTTLE (72189-314-22)", "package_ndc": "72189-314-22", "marketing_start_date": "20220112"}], "brand_name": "AZITHROMYCIN", "product_id": "72189-314_2c3cfbf7-a5af-5075-e063-6294a90a04e5", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "72189-314", "generic_name": "AZITHROMYCIN", "labeler_name": "DirectRx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AZITHROMYCIN", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA207531", "marketing_category": "ANDA", "marketing_start_date": "20220112", "listing_expiration_date": "20261231"}