Buspirone Hydrochloride (Page 5 of 5)

REFERENCE

  1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental Disorders—III, American Psychiatric Association, May 1980.

Patient Instruction Sheet

Rx only

HOW TO USE: Buspirone Hydrochloride Tablets, USP 15 mg and 30 mg

in convenient multi-scored tablet form

Response to buspirone varies among individuals. Your physician may find it necessary to adjust your dosage to obtain the proper response.

This multi-scored tablet design makes dosage adjustments easy. Each tablet is scored and can be broken accurately to provide any of the following dosages.

figure1
(click image for full-size original)

To break a multi-scored tablet accurately and easily, hold the tablet between your thumbs and index fingers close to the appropriate tablet score (groove) as shown in the photo. Then, with the tablet score facing you, apply pressure and snap the tablet segments apart (segments breaking incorrectly should not be used).

Rx only

figure2

Manufactured by

Dr. Reddy’s Laboratories Limited

Bachepalli – 502 325 INDIA

Revised: 1110

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Buspirone Hydrochloride Tablets, USP 5 mg — 100’s Container

Container1
(click image for full-size original)

Buspirone Hydrochloride Tablets, USP 5 mg — Carton

Carton1
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Buspirone Hydrochloride Tablets, USP 10 mg — 100’s Container

Container2
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Buspirone Hydrochloride Tablets, USP 10 mg — Carton

Carton2
(click image for full-size original)

Buspirone Hydrochloride Tablets, USP 15 mg — 100’s Container

Container3
(click image for full-size original)

Buspirone Hydrochloride Tablets, USP 15 mg — Carton

Carton3
(click image for full-size original)

Buspirone Hydrochloride Tablets, USP 30 mg — 100’s Container

Container4
(click image for full-size original)

Buspirone Hydrochloride Tablets, USP 30 mg — Carton

Carton4
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-472
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
silicon dioxide
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape RECTANGLE (ovoid-rectangular shaped, biconvex) Size 7mm
Flavor Imprint Code RDY;472
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-472-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-472-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-472-01 100 TABLET in 1 BOTTLE None
4 NDC:55111-472-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-472-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-472-79)
5 NDC:55111-472-79 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-472-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078246 03/04/2009
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-473
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
silicon dioxide
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape RECTANGLE (ovoid-rectangular shaped, biconvex) Size 9mm
Flavor Imprint Code RDY;473
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-473-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-473-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-473-01 100 TABLET in 1 BOTTLE None
4 NDC:55111-473-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-473-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-473-79)
5 NDC:55111-473-79 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-473-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078246 03/04/2009
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-474
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
silicon dioxide
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape RECTANGLE (flat-rectangular shaped, beveled edged) Size 13mm
Flavor Imprint Code RDY;474
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-474-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-474-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-474-01 100 TABLET in 1 BOTTLE None
4 NDC:55111-474-18 180 TABLET in 1 BOTTLE None
5 NDC:55111-474-05 500 TABLET in 1 BOTTLE None
6 NDC:55111-474-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-474-79)
6 NDC:55111-474-79 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-474-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078246 03/04/2009
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55111-475
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
silicon dioxide
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
sodium starch glycolate type A potato
ferric oxide red
Product Characteristics
Color PINK (light pink to pink) Score 2 pieces
Shape RECTANGLE (flat-rectangular shaped, beveled edged) Size 17mm
Flavor Imprint Code RDY;475
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55111-475-30 30 TABLET in 1 BOTTLE None
2 NDC:55111-475-60 60 TABLET in 1 BOTTLE None
3 NDC:55111-475-01 100 TABLET in 1 BOTTLE None
4 NDC:55111-475-05 500 TABLET in 1 BOTTLE None
5 NDC:55111-475-78 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (55111-475-79)
5 NDC:55111-475-79 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (55111-475-78)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078246 03/04/2009
Labeler — Dr. Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO III 918608162 analysis (55111-472), manufacture (55111-472), analysis (55111-473), manufacture (55111-473), analysis (55111-474), manufacture (55111-474), analysis (55111-475), manufacture (55111-475)

Revised: 11/2010 Dr. Reddy’s Laboratories Limited

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