NDC 0069-0400

Zithromax

Azithromycin Dihydrate

Zithromax is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Azithromycin Dihydrate.

• Product ID: 0069-0400_516adbf5-7841-4624-9dae-4edff6eb8d10
• NDC: 0069-0400
• Product Type: Human Prescription Drug
• Proprietary Name: Zithromax
• Generic Name: Azithromycin Dihydrate
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1997-01-30
• Marketing Category: NDA / NDA
• Application Number: NDA050733
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: AZITHROMYCIN DIHYDRATE
• Active Ingredient Strength: 500 mg/5mL
• Pharm Classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0069-0400-10

10 VIAL in 1 CARTON (0069-0400-10) > 5 mL in 1 VIAL (0069-0400-01)

• Marketing Start Date: 2014-03-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0400-10 [00069040010]

Zithromax INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050733
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-01-30

NDC 0069-0400-01 [00069040001]

Zithromax INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050733
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-01-30

Drug Details

Active Ingredients

Ingredient	Strength
AZITHROMYCIN DIHYDRATE	500 mg/5mL

OpenFDA Data

• SPL SET ID: 8d24bacb-feff-4c6a-b8df-625e1435387a
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 5FD1131I7S
• RxNorm Concept Unique ID - RxCUI:
  • 1668240
  • 1668238

Pharmacological Class

• Macrolide Antimicrobial [EPC]
• Macrolides [CS]

NDC Crossover Matching brand name "Zithromax" or generic name "Azithromycin Dihydrate"

NDC	Brand Name	Generic Name
0069-0400	Zithromax	azithromycin dihydrate
0069-3051	ZITHROMAX	AZITHROMYCIN DIHYDRATE
0069-3060	Zithromax	azithromycin dihydrate
0069-3070	Zithromax	azithromycin dihydrate
0069-3080	ZITHROMAX	AZITHROMYCIN DIHYDRATE
0069-3110	Zithromax	azithromycin dihydrate
70518-0249	Zithromax	Zithromax
70518-0336	Zithromax	Zithromax
70518-0505	Zithromax	Zithromax
0069-3120	Zithromax	Zithromax
0069-3130	Zithromax	Zithromax
0069-3140	Zithromax	Zithromax
0069-3150	Zithromax	Zithromax
50090-0603	Zithromax	Zithromax
55154-2713	Zithromax	Zithromax
61919-555	ZITHROMAX	ZITHROMAX
0069-4061	Zithromax	Zithromax
0069-9500	Zithromax	Zithromax