Buspirone Hydrochloride (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68382-180-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 5 mg

Rx only

100 tablets

ZYDUS

Buspirone Hydrochloride Tablets USP, 5 mg
(click image for full-size original)

NDC 68382-181-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 10 mg

Rx only

1000 tablets

ZYDUS

Buspirone Hydrochloride Tablets USP, 10 mg
(click image for full-size original)

NDC 68382-182-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 15 mg

Rx only

1000 tablets

ZYDUS

Buspirone Hydrochloride Tablets USP, 15 mg
(click image for full-size original)

NDC 68382-183-14 in bottle of 60 tablets

Buspirone Hydrochloride Tablets USP, 30 mg

Rx only

60 tablets

ZYDUS

Buspirone Hydrochloride Tablets USP, 30 mg
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 8mm
Flavor Imprint Code ZE;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-180-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-180-30)
1 NDC:68382-180-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-180-77)
2 NDC:68382-180-01 100 TABLET in 1 BOTTLE None
3 NDC:68382-180-05 500 TABLET in 1 BOTTLE None
4 NDC:68382-180-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078888 05/03/2014
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score 2 pieces
Shape CAPSULE (CAPSULE) Size 10mm
Flavor Imprint Code ZE;37
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-181-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-181-30)
1 NDC:68382-181-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-181-77)
2 NDC:68382-181-01 100 TABLET in 1 BOTTLE None
3 NDC:68382-181-05 500 TABLET in 1 BOTTLE None
4 NDC:68382-181-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078888 05/03/2014
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-182
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 15 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score 3 pieces
Shape CAPSULE (CAPSULE) Size 12mm
Flavor Imprint Code 5;ZE;38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-182-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-182-30)
1 NDC:68382-182-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-182-77)
2 NDC:68382-182-14 60 TABLET in 1 BOTTLE None
3 NDC:68382-182-01 100 TABLET in 1 BOTTLE None
4 NDC:68382-182-28 180 TABLET in 1 BOTTLE None
5 NDC:68382-182-05 500 TABLET in 1 BOTTLE None
6 NDC:68382-182-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078888 05/03/2014
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-183
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUSPIRONE HYDROCHLORIDE (BUSPIRONE) BUSPIRONE HYDROCHLORIDE 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
Product Characteristics
Color WHITE (WHITE TO OFF WHITE) Score 3 pieces
Shape CAPSULE (CAPSULE) Size 17mm
Flavor Imprint Code 10;ZE;39
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-183-77 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68382-183-30)
1 NDC:68382-183-30 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (68382-183-77)
2 NDC:68382-183-14 60 TABLET in 1 BOTTLE None
3 NDC:68382-183-05 500 TABLET in 1 BOTTLE None
4 NDC:68382-183-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078888 05/03/2014
Labeler — Zydus Pharmaceuticals USA Inc. (156861945)
Registrant — Zydus Pharmaceuticals USA Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (68382-180), ANALYSIS (68382-181), ANALYSIS (68382-182), ANALYSIS (68382-183), MANUFACTURE (68382-180), MANUFACTURE (68382-181), MANUFACTURE (68382-182), MANUFACTURE (68382-183)

Revised: 11/2022 Zydus Pharmaceuticals USA Inc.

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