Methylprednisolone (Page 3 of 3)

HOW SUPPLIED

Methylprednisolone Tablets, USP are available in the following strength and package size:

4mg (White, oval-shaped tablets debossed with “TL 001” on one side and quadrisected on the other side)

Unit of use pack (21 tablets) NDC 68001-005-01

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

Manufactured by:

JUBILANT CADISTA PHARMACEUTICALS INC.

Salisbury, MD 21801, USA

For BluePoint Laboratories.

Rev. 08/2018

Package/Label Display Panel

Methylprednildolone rev 08 20
(click image for full-size original)

Package/Label Display Panel

MethylPrednisolone Tablets 4 mg Foil Front
(click image for full-size original)

Package/Label Display Panel

MethylPrednisolone Tablets 4 mg Foil Back
(click image for full-size original)
METHYLPREDNISOLONE
methylprednisolone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-005
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methylprednisolone (Methylprednisolone) Methylprednisolone 4 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Anhydrous Lactose
Magnesium stearate
MICROCRYSTALLINE CELLULOSE
Sodium lauryl sulfate
Starch, Corn
Sodium Starch Glycolate Type A Potato
Product Characteristics
Color WHITE Score 4 pieces
Shape OVAL (Oval) Size 8mm
Flavor Imprint Code TL001
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68001-005-01 21 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040189 08/02/2013
Labeler — BluePoint Laboratories (985523874)
Establishment
Name Address ID/FEI Operations
JUBILANT CADISTA PHARMACEUTICALS, INC. 022490515 MANUFACTURE (68001-005)

Revised: 09/2020 BluePoint Laboratories

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