zithromax

Generic: azithromycin dihydrate

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zithromax
Generic Name azithromycin dihydrate
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

azithromycin dihydrate 500 mg/5mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-3150
Product ID 0069-3150_b0eb7eb4-90fe-4add-a327-e8be68165a3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050733
Listing Expiration 2026-12-31
Marketing Start 1997-01-30

Pharmacologic Class

Classes
macrolide antimicrobial [epc] macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00693150
Hyphenated Format 0069-3150

Supplemental Identifiers

RxCUI
1668238 1668240
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 zithromax (source: ndc)
Generic Name azithromycin dihydrate (source: ndc)
Application Number NDA050733 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0069-3150-83) / 5 mL in 1 VIAL (0069-3150-84)
source: ndc

Packages (1)

0069-3150-83 10 VIAL in 1 CARTON (0069-3150-83) / 5 mL in 1 VIAL (0069-3150-84)

Ingredients (1)

azithromycin dihydrate (500 mg/5mL)

Linked Drug Pages (1)

Zithromax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "b0eb7eb4-90fe-4add-a327-e8be68165a3b", "openfda": {"unii": ["5FD1131I7S"], "rxcui": ["1668238", "1668240"], "spl_set_id": ["3b631aa1-2d46-40bc-a614-d698301ea4f9"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0069-3150-83)  / 5 mL in 1 VIAL (0069-3150-84)", "package_ndc": "0069-3150-83", "marketing_start_date": "19970130"}], "brand_name": "Zithromax", "product_id": "0069-3150_b0eb7eb4-90fe-4add-a327-e8be68165a3b", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Macrolide Antimicrobial [EPC]", "Macrolides [CS]"], "product_ndc": "0069-3150", "generic_name": "azithromycin dihydrate", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zithromax", "active_ingredients": [{"name": "AZITHROMYCIN DIHYDRATE", "strength": "500 mg/5mL"}], "application_number": "NDA050733", "marketing_category": "NDA", "marketing_start_date": "19970130", "listing_expiration_date": "20261231"}