Buspirone Hydrochloride (Page 6 of 6)

HOW SUPPLIED

BusPIRone Hydrochloride Tablets USP, 5 mg are available as white to off-white, round, beveled-edge tablets, debossed “TV” and “53” on one side and scored on the other side, packaged in bottles of 100 (NDC 0093-0053-01) and 500 (NDC 0093-0053-05) tablets.

BusPIRone Hydrochloride Tablets USP, 10 mg are available as white to off-white, round, beveled-edge tablets, debossed “TEVA” on one side and scored and debossed “54” on the other side, packaged in bottles of 100 (NDC 0093-0054-01) and 500 (NDC 0093-0054-05) tablets.

BusPIRone Hydrochloride Tablets USP, 15 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “1003” on bisect segments, and debossed “5” on each trisect segment, and packaged in bottles of 100 (NDC 0093-1003-01) and 500 (NDC 0093-1003-05) tablets.

BusPIRone Hydrochloride Tablets USP, 30 mg are available as white to off-white, rectangular, tablets that can either be bisected or trisected, debossed “TV” and “5200” on bisect segments, and debossed “10” on each trisect segment, and packaged in bottles of 60 (NDC 0093-5200-06) and 500 (NDC 0093-5200-05) tablets.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

REFERENCES

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

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. Z 12/2016

PATIENT INFORMATION

BUSPIRONE HYDROCHLORIDE TABLETS

Rx only

HOW TO USE:

BUSPIRONE HYDROCHLORIDE TABLETS, 15 mg

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

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

If your doctor prescribed the 15 mg tablet:

15 mg (the entire tablet)

15 mg (the entire tablet)

10 mg (two-thirds of a tablet)

10 mg (two-thirds of a tablet)

7.5 mg (one-half of a tablet)

7.5 mg (one-half of a tablet)

5 mg (one-third of a tablet)

5 mg (one-third of a tablet)

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

break tablet 15 mg

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 12/2016

PATIENT INFORMATION

BUSPIRONE HYDROCHLORIDE TABLETS

Rx only

HOW TO USE:

BUSPIRONE HYDROCHLORIDE TABLETS, 30 mg

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

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

If your doctor prescribed the 30 mg tablet:

30 mg (the entire tablet)

30 mg (the entire tablet)

20 mg (two-thirds of a tablet)

20 mg (two-thirds of a tablet)

15 mg (one-half of a tablet)

15 mg (one-half of a tablet)

10 mg (one-third of a tablet)

10 mg (one-third of a tablet)

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

break tablet 30 mg

Manufactured In Croatia By:

Pliva Hrvatska d.o.o.

Zagreb, Croatia

Manufactured For:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 12/2016

Package/Label Display Panel

NDC 0093-0053 -01

BusPIRone
Hydrochloride
Tablets USP 5 mg

Rx only

100 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-0054 -01

BusPIRone
Hydrochloride
Tablets USP 10 mg

Rx only

100 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-1003 -01

BusPIRone
Hydrochloride
Tablets USP
15 mg

PHARMACIST: PLEASE DISPENSE WITHATTACHED PATIENT INFORMATION LEAFLET

Rx only

100 TABLETS

TEVA

image
(click image for full-size original)

Package/Label Display Panel

NDC 0093-5200 -06

BusPIRone
Hydrochloride
Tablets USP
30 mg

PHARMACIST: PLEASE DISPENSE WITHATTACHED PATIENT INFORMATION LEAFLET

Rx only

60 TABLETS

TEVA

image
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0053
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code TV;53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0053-01 100 TABLET in 1 BOTTLE None
2 NDC:0093-0053-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075022 02/28/2002
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-0054
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code TEVA;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-0054-01 100 TABLET in 1 BOTTLE None
2 NDC:0093-0054-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075022 02/28/2002
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-1003
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 3 pieces
Shape RECTANGLE Size 15mm
Flavor Imprint Code TV;1003;5;5;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-1003-01 100 TABLET in 1 BOTTLE None
2 NDC:0093-1003-05 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075022 03/01/2002
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-5200
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 3 pieces
Shape RECTANGLE Size 17mm
Flavor Imprint Code TV;5200;10;10;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0093-5200-05 500 TABLET in 1 BOTTLE None
2 NDC:0093-5200-06 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075022 03/26/2004
Labeler — Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 12/2016 Teva Pharmaceuticals USA, Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.