Tizanidine (Page 6 of 6)

NDC 50268-760-15
TIANIDINE
Tablets USP
4 mg
Rx Only
50 Tablets (5 x10) Unit Dose
STOP: Tizanidine Tablets are not
interchangeable with Tizanidine Capsules
Each tablet contains:
4.576 mg tizanidine hydrochloride USP,
equivalent to 4 mg tizanidine base.
Refer to package insert for prescribing
information.
Store at controlled room temperature 15°-30°C
(59°-86°F).
KEEP THIS AND ALL MEDICATION OUT OF THE
REACH OF CHILDREN.
Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
AvPAK
A Product of AvKARE
Mfg. Rev. 04/12
AV 08/17

4
(click image for full-size original)
TIZANIDINE tizanidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-759(NDC:55111-179)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIZANIDINE HYDROCHLORIDE (TIZANIDINE) TIZANIDINE 2 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
STEARIC ACID
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape OVAL Size 8mm
Flavor Imprint Code R;179
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-759-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-759-11)
1 NDC:50268-759-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-759-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076286 08/24/2017
TIZANIDINE tizanidine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-760(NDC:55111-180)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIZANIDINE HYDROCHLORIDE (TIZANIDINE) TIZANIDINE 4 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
STEARIC ACID
Product Characteristics
Color white (white to off-white) Score 4 pieces
Shape OVAL Size 11mm
Flavor Imprint Code R;180
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-760-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (50268-760-11)
1 NDC:50268-760-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (50268-760-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076286 08/24/2017
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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