azithromycin

Generic: azithromycin

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin
Labeler chartwell rx, llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

azithromycin monohydrate 200 mg/5mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-705
Product ID 62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065488
Listing Expiration 2026-12-31
Marketing Start 2015-05-15

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135705
Hyphenated Format 62135-705

Supplemental Identifiers

RxCUI
141963 308459
UPC
0362135705435 0362135704513 0362135705527 0362135705510
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 azithromycin (source: ndc)
Generic Name azithromycin (source: ndc)
Application Number ANDA065488 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/5mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (62135-705-43)
  • 15 mL in 1 BOTTLE (62135-705-51)
  • 22.5 mL in 1 BOTTLE (62135-705-52)
source: ndc

Packages (3)

62135-705-43 30 mL in 1 BOTTLE (62135-705-43) 62135-705-51 15 mL in 1 BOTTLE (62135-705-51) 62135-705-52 22.5 mL in 1 BOTTLE (62135-705-52)

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": "15af5062-22b6-c8b6-e063-6294a90a7df3", "openfda": {"upc": ["0362135705435", "0362135704513", "0362135705527", "0362135705510"], "unii": ["JTE4MNN1MD"], "rxcui": ["141963", "308459"], "spl_set_id": ["2c9de2e9-c20c-4660-a272-a22019f9fb02"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (62135-705-43)", "package_ndc": "62135-705-43", "marketing_start_date": "20240307"}, {"sample": false, "description": "15 mL in 1 BOTTLE (62135-705-51)", "package_ndc": "62135-705-51", "marketing_start_date": "20240307"}, {"sample": false, "description": "22.5 mL in 1 BOTTLE (62135-705-52)", "package_ndc": "62135-705-52", "marketing_start_date": "20240307"}], "brand_name": "Azithromycin", "product_id": "62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3", "dosage_form": "SUSPENSION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "62135-705", "generic_name": "Azithromycin", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "200 mg/5mL"}], "application_number": "ANDA065488", "marketing_category": "ANDA", "marketing_start_date": "20150515", "listing_expiration_date": "20261231"}