DailyMed - AZITHROMYCIN powder, for suspension

NDC Code(s): 70771-1422-1, 70771-1423-2, 70771-1424-2, 70771-1425-2
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 9, 2025

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION

Close
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1422-1 - Azithromycin for oral suspension, 300 mg - 100 mg/5 mL - Rx only - NDC 70771-1423-2 - Azithromycin for oral suspension, 600 mg - 200 mg/5 mL - Rx only - NDC 70771-1424-2 - Azithromycin ...

NDC 70771-1422-1

Azithromycin for oral suspension, 300 mg

100 mg/5 mL

Rx only

NDC 70771-1423-2

Azithromycin for oral suspension, 600 mg

200 mg/5 mL

Rx only

NDC 70771-1424-2

Azithromycin for oral suspension, 900 mg

200 mg/5 mL

Rx only

NDC 70771-1425-2

Azithromycin for oral suspension, 1200 mg

200 mg/5 mL

Rx only

Close

INGREDIENTS AND APPEARANCE

Product Information

AZITHROMYCIN azithromycin powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1422
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	100 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO LIGHT PINK)	Score
Shape		Size
Flavor	CHERRY (CHERRY) , BANANA (RIPE BANANA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1422-1	1 in 1 CARTON	08/06/2018
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211147	08/06/2018

AZITHROMYCIN azithromycin powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1423
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO LIGHT PINK)	Score
Shape		Size
Flavor	CHERRY (CHERRY) , BANANA (RIPE BANANA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1423-2	1 in 1 CARTON	08/06/2018
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211147	08/06/2018

AZITHROMYCIN azithromycin powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1424
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO LIGHT PINK)	Score
Shape		Size
Flavor	CHERRY (CHERRY) , BANANA (RIPE BANANA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1424-2	1 in 1 CARTON	08/06/2018
1		22.5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211147	08/06/2018

AZITHROMYCIN azithromycin powder, for suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1425
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AZITHROMYCIN DIHYDRATE (UNII: 5FD1131I7S) (AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)	AZITHROMYCIN ANHYDROUS	200 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE (WHITE TO LIGHT PINK)	Score
Shape		Size
Flavor	CHERRY (CHERRY) , BANANA (RIPE BANANA)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70771-1425-2	1 in 1 CARTON	08/06/2018
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA211147	08/06/2018

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (677605858)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		677605858	ANALYSIS(70771-1422, 70771-1423, 70771-1424, 70771-1425) , MANUFACTURE(70771-1422, 70771-1423, 70771-1424, 70771-1425)

View All Sections

Published Date (What is this?)	Version	Files
Jan 10, 2025	5 (current)	download
Nov 7, 2022	4	download
Aug 19, 2020	3	download
May 14, 2019	2	download
Aug 6, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN
2	141963	azithromycin 40 MG/ML Oral Suspension	SCD
3	141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY
4	141963	azithromycin 200 MG per 5 ML Oral Suspension	SY
5	141963	azithromycin 600 MG per 15 ML Oral Suspension	SY
6	308459	azithromycin 100 MG in 5 mL Oral Suspension	PSN
7	308459	azithromycin 20 MG/ML Oral Suspension	SCD
8	308459	azithromycin 100 MG per 5 ML Oral Suspension	SY

Label: AZITHROMYCIN powder, for suspension

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	70771-1422-1
2	70771-1423-2
3	70771-1424-2
4	70771-1425-2

Label: AZITHROMYCIN powder, for suspension

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

AZITHROMYCIN powder, for suspension

Number of versions: 5

AZITHROMYCIN powder, for suspension

AZITHROMYCIN powder, for suspension

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

AZITHROMYCIN powder, for suspension

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.