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.

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

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

Buspirone Hydrochloride Tablets, USP 5 mg — Carton

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

Buspirone Hydrochloride Tablets, USP 10 mg — Carton

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

Buspirone Hydrochloride Tablets, USP 15 mg — Carton

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

Buspirone Hydrochloride Tablets, USP 30 mg — Carton

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