Primidone (Page 3 of 3)

Package/Label Display Panel – Carton – 50 mg

50 mg Primidone Tablets Carton
(click image for full-size original)

NDC 68084- 202 -01

Primidone
Tablets, USP

50 mg

100 Tablets (10 x 10)               Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Primidone, USP………………………………………………………. 50 mg

Usual Dosage: 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 # 0527-1301, Lannett Company, Inc.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

084340 0220201/1118A

Package/Label Display Panel – Blister – 50 mg

50 mg Primidone Tablet Blister
(click image for full-size original)

Primidone Tablet, USP

50 mg

Package/Label Display Panel – Carton – 250 mg

250 mg Primidone Tablets Carton
(click image for full-size original)

NDC 68084- 203 -01

Primidone
Tablets, USP

250 mg

100 Tablets (10 x 10)              Rx Only

PHARMACIST: Dispense with the accompanying Medication
Guide to each patient.

Each Tablet Contains:
Primidone, USP……………………………………………………250 mg

Usual Dosage: 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 # 0527-1231, Lannett Company, Inc.

Distributed by:
American Health Packaging
Columbus, Ohio 43217

085014 0220301/0320

Package/Label Display Panel – Blister – 250 mg

250 mg Primidone Tablet Blister
(click image for full-size original)

Primidone Tablet, USP

250 mg

PRIMIDONE primidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-202(NDC:0527-1301)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRIMIDONE (PRIMIDONE) PRIMIDONE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
METHYLCELLULOSE (400 MPA.S)
ACACIA
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code LAN;1301
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-202-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-202-11)
1 NDC:68084-202-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-202-01)
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084903 06/12/2007
PRIMIDONE primidone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-203(NDC:0527-1231)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRIMIDONE (PRIMIDONE) PRIMIDONE 250 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
METHYLCELLULOSE (400 MPA.S)
ACACIA
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LAN;1231
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-203-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-203-11)
1 NDC:68084-203-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-203-01)
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 ANDA084903 06/12/2007
Labeler — American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack (68084-202), repack (68084-203)

Revised: 10/2022 American Health Packaging

Page 3 of 3 1 2 3

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