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

R_x only

100 tablets

ZYDUS

NDC 68382-181-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 10 mg

R_x only

1000 tablets

ZYDUS

NDC 68382-182-01 in bottle of 100 tablets

Buspirone Hydrochloride Tablets USP, 15 mg

R_x only

1000 tablets

ZYDUS

NDC 68382-183-14 in bottle of 60 tablets

Buspirone Hydrochloride Tablets USP, 30 mg

R_x only

60 tablets

ZYDUS

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.