azithromycin

Generic: azithromycin monohydrate

Labeler: athenex pharmaceutical division, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin monohydrate
Labeler athenex pharmaceutical division, llc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin monohydrate 500 mg/5mL

Manufacturer
Athenex Pharmaceutical Division, LLC.

Identifiers & Regulatory

Product NDC 70860-100
Product ID 70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065501
Marketing Start 2017-01-01
Marketing End 2027-03-31

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70860100
Hyphenated Format 70860-100

Supplemental Identifiers

RxCUI
1668238
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 monohydrate (source: ndc)
Application Number ANDA065501 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-100-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70860-100-41)
source: ndc

Packages (1)

70860-100-10 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-100-10) / 5 mL in 1 VIAL, SINGLE-DOSE (70860-100-41)

Ingredients (1)

azithromycin monohydrate (500 mg/5mL)

Linked Drug Pages (1)

Azithromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2cc930e3-dd57-6e2f-e063-6294a90a3111", "openfda": {"unii": ["JTE4MNN1MD"], "rxcui": ["1668238"], "spl_set_id": ["324330c5-20fe-4b22-adf2-14a6e91e71ef"], "manufacturer_name": ["Athenex Pharmaceutical Division, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (70860-100-10)  / 5 mL in 1 VIAL, SINGLE-DOSE (70860-100-41)", "package_ndc": "70860-100-10", "marketing_end_date": "20270331", "marketing_start_date": "20170101"}], "brand_name": "Azithromycin", "product_id": "70860-100_2cc930e3-dd57-6e2f-e063-6294a90a3111", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70860-100", "generic_name": "azithromycin monohydrate", "labeler_name": "Athenex Pharmaceutical Division, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN MONOHYDRATE", "strength": "500 mg/5mL"}], "application_number": "ANDA065501", "marketing_category": "ANDA", "marketing_end_date": "20270331", "marketing_start_date": "20170101"}