PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-781-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 5 mg

Rx only

100 tablets

Buspirone Hydrochloride Tablets USP, 5 mg

NDC 65841-842-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 7.5 mg

Rx only

100 tablets

NDC 65841-782-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 10 mg

Rx only

100 tablets

Buspirone Hydrochloride Tablets USP, 10 mg

NDC 65841-783-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 15 mg

Rx only

100 tablets

Buspirone Hydrochloride Tablets USP, 15 mg

NDC 65841-784-14 in bottle of 60 tablets

Buspirone Hydrochloride Tablets USP, 30 mg

Rx only

60 tablets

Buspirone Hydrochloride Tablets USP, 30 mg

BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-781
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)	BUSPIRONE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	CAPSULE (CAPSULE)	Size	8mm
Flavor		Imprint Code	ZE;36
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-781-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
2	NDC:65841-781-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
3	NDC:65841-781-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
4	NDC:65841-781-77	100 in 1 CARTON	05/03/2014
4	NDC:65841-781-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078888	05/03/2014

BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-782
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)	BUSPIRONE HYDROCHLORIDE	10 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	CAPSULE (CAPSULE)	Size	10mm
Flavor		Imprint Code	ZE;37
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-782-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
2	NDC:65841-782-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
3	NDC:65841-782-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
4	NDC:65841-782-77	100 in 1 CARTON	05/03/2014
4	NDC:65841-782-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078888	05/03/2014

BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-783
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)	BUSPIRONE HYDROCHLORIDE	15 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	3 pieces
Shape	CAPSULE (CAPSULE)	Size	12mm
Flavor		Imprint Code	5;ZE;38
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-783-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
2	NDC:65841-783-28	180 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
3	NDC:65841-783-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
4	NDC:65841-783-77	100 in 1 CARTON	05/03/2014
4	NDC:65841-783-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product
5	NDC:65841-783-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
6	NDC:65841-783-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078888	05/03/2014

BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-784
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)	BUSPIRONE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	3 pieces
Shape	CAPSULE (CAPSULE)	Size	17mm
Flavor		Imprint Code	10;ZE;39
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-784-14	60 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
2	NDC:65841-784-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	05/03/2014
3	NDC:65841-784-77	100 in 1 CARTON	05/03/2014
3	NDC:65841-784-30	1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078888	05/03/2014

BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-842
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BUSPIRONE HYDROCHLORIDE (UNII: 207LT9J9OC) (BUSPIRONE - UNII:TK65WKS8HL)	BUSPIRONE HYDROCHLORIDE	7.5 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	CAPSULE (CAPSULE)	Size	9mm
Flavor		Imprint Code	6;23
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-842-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2023
2	NDC:65841-842-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2023
3	NDC:65841-842-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2023
4	NDC:65841-842-30	100 in 1 CARTON	03/21/2023
4		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078888	03/21/2023

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(65841-781, 65841-782, 65841-783, 65841-784, 65841-842) , MANUFACTURE(65841-781, 65841-782, 65841-783, 65841-784, 65841-842)