NDC 0069-3051

ZITHROMAX

Azithromycin Dihydrate

ZITHROMAX is a Oral Powder, For Suspension 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: 0069-3051_04ff75a3-1031-4a4e-849a-30cf77a53a7b
• NDC: 0069-3051
• Product Type: Human Prescription Drug
• Proprietary Name: ZITHROMAX
• Generic Name: Azithromycin Dihydrate
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 1994-09-28
• Marketing Category: NDA / NDA
• Application Number: NDA050693
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: AZITHROMYCIN DIHYDRATE
• Active Ingredient Strength: 1 g/1
• Pharm Classes: Macrolide Antimicrobial [EPC], Macrolides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0069-3051-07

10 PACKET in 1 BOX (0069-3051-07) > 1 POWDER, FOR SUSPENSION in 1 PACKET (0069-3051-01)

• Marketing Start Date: 1994-09-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-3051-01 [00069305101]

ZITHROMAX POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA050693
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-03-25

NDC 0069-3051-07 [00069305107]

ZITHROMAX POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA050693
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-09-28

NDC 0069-3051-75 [00069305175]

ZITHROMAX POWDER, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA050693
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-09-28

Drug Details

Active Ingredients

Ingredient	Strength
AZITHROMYCIN DIHYDRATE	1 g/1

OpenFDA Data

• SPL SET ID: b749df83-49b0-433e-8a62-589a048dd716
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 5FD1131I7S
• RxNorm Concept Unique ID - RxCUI:
  • 211511
  • 861416
  • 861417
  • 204844
• UPC Code:
  • 0300693080304

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