Buspirone Hydrochloride (Page 6 of 6)

HOW SUPPLIED

Buspirone Hydrochloride Tablets, USP, are supplied as follows:

Buspirone Hydrochloride Tablets, USP 5 mg:

White to off white, round flat faced beveled edge tablet, debossed with “244” on one side and “U” on either side of the break line.

Bottle of 100: NDC 29300-244-01

Bottle of 500: NDC 29300-244-05

Buspirone Hydrochloride Tablets, USP 10 mg:

White to off white, round flat faced beveled edge tablet, debossed with “245” on one side and “U” on either side of the break line.

Bottle of 100: NDC 29300-245-01

Bottle of 500: NDC 29300-245-05

Buspirone Hydrochloride Tablets, USP 15 mg:

White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with “U” and “246” on one side of the trisect segments and plain on other side of the trisect segment.

Bottle of 60: NDC 29300-477-16

Bottle of 100: NDC 29300-477-01

Bottle of 180: NDC 29300-477-18

Bottle of 500: NDC 29300-477-05

Buspirone Hydrochloride Tablets, USP 30 mg:

White to off white, rectangular flat faced beveled edge tablet that can either be bisected or trisected, debossed with “U” and “247” on one side of the trisect segments and plain on other side of the trisect segment.

Bottle of 60: NDC 29300-478-16

Bottle of 100: NDC 29300-478-01

Bottle of 500: NDC 29300-478-05

Store at 200 to 250 C (680 to 770 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 drugs out of reach of children.

Additional patient information leaflets can be obtained by calling Unichem at 1-866-562-4616.

REFERENCES

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

Manufactured by:

UNICHEM LABORATORIES LTD.

Ind. Area, Meerut Road, Ghaziabad – 201 003, India

and

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez,

Goa — 403 511, India

Manufactured for:

Image

East Brunswick, NJ 08816

05-R-10/2023

13015142

PATIENT MEDICATION INFORMATION SECTION

Buspirone Hydrochloride Tablets, USP

Rx Only

HOW TO USE:

Buspirone Hydrochloride Tablets, USP, 15 mg and 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 15 mg tablet : If your doctor prescribed the 30 mg tablet :
15 mg (the entire tablet) 30 mg (the entire tablet)
ImageImage
10 mg (two-thirds of a tablet) 20 mg (two-thirds of a tablet)
ImageImage
7.5 mg (one-half of a tablet) 15 mg (one-half of a tablet)
ImageImage
5 mg (one-third of a tablet) 10 mg (one-third of a tablet)
ImageImage

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).

Image

Manufactured by:

UNICHEM LABORATORIES LTD.

Ind. Area, Meerut Road, Ghaziabad – 201 003, India

and

UNICHEM LABORATORIES LTD.

Pilerne Ind. Estate, Pilerne, Bardez,

Goa — 403 511, India

Manufactured for:

Image

East Brunswick, NJ 08816

05-R-10/2023

13015142

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 mg 100 T
(click image for full-size original)
10 mg 100 T
(click image for full-size original)
15 mg 100 T
(click image for full-size original)
30 mg 100 T
(click image for full-size original)
Buspirone 15 mg -100T New NDC
(click image for full-size original)
Buspirone 30 mg -100T New NDC
(click image for full-size original)
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-244
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND (flat faced beveled edge) Size 6mm
Flavor Imprint Code U;244
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-244-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-244-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 11/14/2019
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-245
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND (flat faced beveled edge) Size 8mm
Flavor Imprint Code U;245
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-245-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-245-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 11/14/2019
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-246
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 3 pieces
Shape RECTANGLE (flat faced beveled edge) Size 16mm
Flavor Imprint Code U;246
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-246-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-246-18 180 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:29300-246-05 500 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:29300-246-16 60 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 11/14/2019
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-247
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 3 pieces
Shape RECTANGLE (flat faced beveled edge) Size 17mm
Flavor Imprint Code U;247
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-247-16 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-247-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:29300-247-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 11/14/2019
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-477
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 3 pieces
Shape RECTANGLE (flat faced beveled edge) Size 16mm
Flavor Imprint Code U;246
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-477-16 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-477-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:29300-477-18 180 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:29300-477-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 10/17/2023
BUSPIRONE HYDROCHLORIDE buspirone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-478
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 3 pieces
Shape RECTANGLE (flat faced beveled edge) Size 17mm
Flavor Imprint Code U;247
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29300-478-16 60 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:29300-478-01 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:29300-478-05 500 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210907 10/17/2023
Labeler — Unichem Pharmaceuticals (USA), Inc. (181620514)

Revised: 12/2023 Unichem Pharmaceuticals (USA), Inc.

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