NDC 0069-4061

Zithromax

Azithromycin Dihydrate

Zithromax is a Oral Tablet, Film Coated 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: 0069-4061_0a7a028c-ef61-4dcc-8ab6-f20cf8270a86
• NDC: 0069-4061
• Product Type: Human Prescription Drug
• Proprietary Name: Zithromax
• Generic Name: Azithromycin Dihydrate
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-05-17
• Marketing Category: NDA / NDA
• Application Number: NDA050711
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: AZITHROMYCIN DIHYDRATE
• Active Ingredient Strength: 250 mg/1
• Pharm Classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0069-4061-01

30 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01)

• Marketing Start Date: 2020-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-4061-01 [00069406101]

Zithromax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA050711
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-17
• Marketing End Date: 2019-05-17

NDC 0069-4061-75 [00069406175]

Zithromax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA050711
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-05-17
• Marketing End Date: 2019-05-17

NDC 0069-4061-89 [00069406189]

Zithromax TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA050711
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-05-17
• Marketing End Date: 2019-05-17

Drug Details

Active Ingredients

Ingredient	Strength
AZITHROMYCIN DIHYDRATE	250 mg/1

OpenFDA Data

• SPL SET ID: db52b91e-79f7-4cc1-9564-f2eee8e31c45
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 5FD1131I7S
• UPC Code:
  • 0300693060306
  • 0300693070305
  • 0300693140190
  • 0300693130191
  • 0300693120192

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