azithromycin

Generic: azithromycin dihydrate

Labeler: slate run pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name azithromycin
Generic Name azithromycin dihydrate
Labeler slate run pharmaceuticals
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin dihydrate 500 mg/5mL

Manufacturer
Slate Run Pharmaceuticals

Identifiers & Regulatory

Product NDC 70436-019
Product ID 70436-019_ebe5ec1e-9891-ae48-e053-2a95a90afff6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203412
Listing Expiration 2026-12-31
Marketing Start 2018-12-19

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70436019
Hyphenated Format 70436-019

Supplemental Identifiers

RxCUI
1668238
UPC
0370436019823
UNII
5FD1131I7S

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 dihydrate (source: ndc)
Application Number ANDA203412 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (70436-019-82) / 5 mL in 1 VIAL
source: ndc

Packages (1)

70436-019-82 10 VIAL in 1 BOX (70436-019-82) / 5 mL in 1 VIAL

Ingredients (1)

azithromycin dihydrate (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": "ebe5ec1e-9891-ae48-e053-2a95a90afff6", "openfda": {"upc": ["0370436019823"], "unii": ["5FD1131I7S"], "rxcui": ["1668238"], "spl_set_id": ["8acce3c1-f4be-4968-a71f-3ffd9fbaa4a4"], "manufacturer_name": ["Slate Run Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (70436-019-82)  / 5 mL in 1 VIAL", "package_ndc": "70436-019-82", "marketing_start_date": "20181219"}], "brand_name": "Azithromycin", "product_id": "70436-019_ebe5ec1e-9891-ae48-e053-2a95a90afff6", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "70436-019", "generic_name": "Azithromycin Dihydrate", "labeler_name": "Slate Run Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Azithromycin", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/5mL"}], "application_number": "ANDA203412", "marketing_category": "ANDA", "marketing_start_date": "20181219", "listing_expiration_date": "20261231"}