DailyMed - BUSPIRONE HYDROCHLORIDE tablet

NDC Code(s): 65841-781-01, 65841-781-05, 65841-781-10, 65841-781-30, view more
65841-781-77, 65841-782-01, 65841-782-05, 65841-782-10, 65841-782-30, 65841-782-77, 65841-783-01, 65841-783-05, 65841-783-10, 65841-783-14, 65841-783-28, 65841-783-30, 65841-783-77, 65841-784-10, 65841-784-14, 65841-784-30, 65841-784-77, 65841-842-01, 65841-842-05, 65841-842-10, 65841-842-30
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated March 27, 2023

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-781-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 5 mg

Rx only

100 tablets

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

NDC 65841-783-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 15 mg

Rx only

100 tablets

NDC 65841-784-14 in bottle of 60 tablets

Buspirone Hydrochloride Tablets USP, 30 mg

Rx only

60 tablets

INGREDIENTS AND APPEARANCE

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)

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Published Date (What is this?)	Version	Files
Mar 30, 2023	7 (current)	download
Aug 15, 2022	6	download
Jul 31, 2020	5	download
Jan 24, 2020	4	download
Dec 17, 2018	3	download
Apr 17, 2017	2	download
May 5, 2014	1	download

	RxCUI	RxNorm NAME	RxTTY
1	866018	busPIRone HCl 15 MG Oral Tablet	PSN
2	866018	buspirone hydrochloride 15 MG Oral Tablet	SCD
3	866018	buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet	SY
4	866083	busPIRone HCl 10 MG Oral Tablet	PSN
5	866083	buspirone hydrochloride 10 MG Oral Tablet	SCD
6	866083	buspirone HCl 10 MG (buspirone 9.1 MG) Oral Tablet	SY
7	866090	busPIRone HCl 30 MG Oral Tablet	PSN
8	866090	buspirone hydrochloride 30 MG Oral Tablet	SCD
9	866090	buspirone hydrochloride 30 MG (buspirone 27.4 MG) Oral Tablet	SY
10	866094	busPIRone HCl 5 MG Oral Tablet	PSN
11	866094	buspirone hydrochloride 5 MG Oral Tablet	SCD
12	866094	buspirone hydrochloride 5 MG (buspirone 4.6 MG) Oral Tablet	SY
13	866111	busPIRone HCl 7.5 MG Oral Tablet	PSN
14	866111	buspirone hydrochloride 7.5 MG Oral Tablet	SCD
15	866111	buspirone HCl 7.5 MG (buspirone 6.9 MG) Oral Tablet	SY

Label: BUSPIRONE HYDROCHLORIDE tablet

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	NDC
1	65841-781-01
2	65841-781-05
3	65841-781-10
4	65841-781-30
5	65841-781-77
6	65841-782-01
7	65841-782-05
8	65841-782-10
9	65841-782-30
10	65841-782-77
11	65841-783-01
12	65841-783-05
13	65841-783-10
14	65841-783-14
15	65841-783-28
16	65841-783-30
17	65841-783-77
18	65841-784-10
19	65841-784-14
20	65841-784-30
21	65841-784-77
22	65841-842-01
23	65841-842-05
24	65841-842-10
25	65841-842-30

Label: BUSPIRONE HYDROCHLORIDE tablet

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More Info For This Drug

Drug Label Information

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Safety

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More Info on this Drug

BUSPIRONE HYDROCHLORIDE tablet

Number of versions: 7

BUSPIRONE HYDROCHLORIDE tablet

BUSPIRONE HYDROCHLORIDE tablet

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BUSPIRONE HYDROCHLORIDE tablet

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