Tetrabenazine (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tetrabenazine Tablets 12.5 mg

NDC 68180-408-58

Pack of 112

Container Label
(click image for full-size original)

12.5 mg

Tetrabenazine Tablets 25 mg

NDC 68180-409-58

Pack of 112

Container Label
(click image for full-size original)

25 mg

TETRABENAZINE tetrabenazine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-408
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRABENAZINE (TETRABENAZINE) TETRABENAZINE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A CORN
STARCH, CORN
TALC
Product Characteristics
Color WHITE (off-white) Score no score
Shape ROUND (flat faced tablets with bevelled edges) Size 6mm
Flavor Imprint Code LU;L71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-408-58 112 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210544 11/19/2018
TETRABENAZINE tetrabenazine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-409
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRABENAZINE (TETRABENAZINE) TETRABENAZINE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A CORN
STARCH, CORN
TALC
Product Characteristics
Color YELLOW (Light yellow) Score 2 pieces
Shape ROUND (flat faced tablets with bevelled edges) Size 6mm
Flavor Imprint Code L;U;L72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-409-58 112 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210544 11/19/2018
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (68180-408), MANUFACTURE (68180-409), PACK (68180-408), PACK (68180-409)

Revised: 12/2019 Lupin Pharmaceuticals, Inc.

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