Prescription Drug Information: Benztropine Mesylate (Page 2 of 2)

HOW SUPPLIED

Benztropine Mesylate Tablets, USP are available as follows:

0.5 mg: white, round, flat-faced beveled edge, scored tablets, debossed “2325” on one side and debossed “V” on the reverse side, supplied in: Unit dose packages of 100 (10 x 10) NDC 68084-381-01.

1 mg: white, oval, scored tablets, debossed “2326” on one side and debossed “V” on the reverse side, supplied in: Unit dose packages of 100 (10 x 10) NDC 68084-388-01.

2 mg: white, round, flat-faced beveled edge, scored tablets, debossed “2327” on one side and debossed “V” on the reverse side, supplied in: Unit dose packages of 100 (10 x 10) NDC 68084-389-01.

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

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

*Duvoisin, R.C.; Katz, R.J.; Amer. Med. Ass. 206:1963–1965, Nov. 25, 1968.

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows:
(0.5 mg / 100 UD) NDC 68084-381-01 packaged from NDC 0603-2433
(1 mg / 100 UD) NDC 68084-388-01 packaged from NDC 0603-2434
(2 mg / 100 UD) NDC 68084-389-01 packaged from NDC 0603-2435

Distributed by
American Health Packaging Columbus, OH 43217

8238101/1222

Package/Label Display Panel – Carton – 0.5 mg

0.5 mg Benztropine Mesylate Tablets Tablets
(click image for full-size original)

NDC 68084- 381 -01

Benztropine Mesylate
Tablets, USP

0.5 mg

100 Tablets (10 x 10)                 Rx Only

Each Tablet Contains:
Benztropine Mesylate, USP……………………………………………..0.5 mg

Usual Adult Dosage: For parkinsonism, 1 to 2 mg daily. For drug
induced extrapyramidal disorders, 1 to 4 mg once or twice a day.
See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0603-2433, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

038101 0238101/1222

Package/Label Display Panel – Blister – 0.5 mg

0.5 mg Benztropine Mesylate Tablet Blister
(click image for full-size original)

Benztropine Mesylate Tablet, USP

0.5 mg

Package/Label Display Panel – Carton – 1 mg

1 mg Benztropine Mesylate Carton
(click image for full-size original)

NDC 68084- 388 -01

Benztropine Mesylate
Tablets, USP

1 mg

100 Tablets (10 x 10)                 Rx Only

Each Tablet Contains:
Benztropine Mesylate, USP………………………………………………..1 mg

Usual Adult Dosage: For parkinsonism, 1 to 2 mg daily. For drug
induced extrapyramidal disorders, 1 to 4 mg once or twice a day.
See full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0603-2434, Par Pharmaceutical.

Distributed by: American Health Packaging, Columbus, Ohio 43217

038801 0238801/0923

Package/Label Display Panel – Blister – 1 mg

1 mg Benztropine Mesylate Tablet Blister
(click image for full-size original)

Benztropine Mesylate Tablets, USP

1 mg

Package/Label Display Panel – Carton – 2 mg

2 mg Benztropine Mesylate Tablets Carton
(click image for full-size original)

NDC 68084- 389 -01

Benztropine Mesylate
Tablets, USP

2 mg

100 Tablets (10 x 10)                 Rx Only

Each Tablet Contains:
Benztropine Mesylate, USP……………………………………………….. 2 mg

Usual Adult Dosage: For parkinsonism, 1 to 2 mg daily. For drug
induced extrapyramidal disorders, 1 to 4 mg once or twice a day.
See package insert for full prescribing information.

Store at 20° to 25°C (68° to 77°F); excursions permitted between
15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

The drug product contained in this package is from
NDC # 0603-2435, Par Pharmaceutical.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

038901 0238901/0822

Package/Label Display Panel – Blister – 2 mg

2 mg Benztropine Mesylate Tablet Blister
(click image for full-size original)

Benztropine Mesylate Tablets, USP

2 mg

BENZTROPINE MESYLATE benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-381(NDC:0603-2433)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 2325;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-381-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-381-11)
1 NDC:68084-381-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-381-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040715 11/09/2009
BENZTROPINE MESYLATE benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-388(NDC:0603-2434)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 1 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score 2 pieces
Shape OVAL Size 10mm
Flavor Imprint Code 2326;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-388-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-388-11)
1 NDC:68084-388-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-388-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040715 12/29/2009
BENZTROPINE MESYLATE benztropine mesylate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-389(NDC:0603-2435)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZTROPINE MESYLATE (BENZTROPINE) BENZTROPINE MESYLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 2327;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-389-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-389-11)
1 NDC:68084-389-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-389-01)
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040715 07/01/2013
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-381), repack (68084-388), repack (68084-389)

Revised: 02/2024 American Health Packaging

Page 2 of 2 1 2

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.