METHYLPREDNISOLONE (Page 3 of 3)

HOW SUPPLIED

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

4 mg are white oval tablets with “MP” debossed on one side and quadrisect scored on the other side.

Bottles of 100 NDC 57582-101-01

Unit-of–use cartons of 21 tablets NDC 57582-101-02

Store at controlled room temperature 20° to 25°C (68° to 77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Protect from light.

REFERENCES

1 Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases. Philadelphia: WBSaunders Company 1992:1050–1.
2 Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954–63.

company logo

Manufactured by
Tianjin Kingyork Pharmaceuticals Co., Ltd.

Tianjin,300457,China

Revised : 02-2022-00

———PRINCIPAL DISPLAY PANEL———

NDC 57582-101-01

Methylprednisolone
Tablets USP

4 mg

Rx Only 100 Tablets

Manufactured by
Tianjin Kingyork Pharmaceuticals Co., Ltd.
(Tianjin, 300457, China)

bottle container
(click image for full-size original)
bottle carton
(click image for full-size original)

———PRINCIPAL DISPLAY PANEL———

NDC 57582-101-02
Methylprednisolone
Tablets USP
4 mg
Rx Only 21 Tablets
Manufactured by
Tianjin Kingyork Pharmaceuticals Co., Ltd.
(Tianjin, 300457, China)

blister back
(click image for full-size original)
blister carton
(click image for full-size original)
blister front
(click image for full-size original)
METHYLPREDNISOLONE
methylprednisolone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57582-101
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
Product Characteristics
Color WHITE Score 4 pieces
Shape OVAL Size 8mm
Flavor Imprint Code MP
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57582-101-01 100 TABLET in 1 BOTTLE None
2 NDC:57582-101-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 21 TABLET in 1 BLISTER PACK This package is contained within the CARTON (57582-101-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204072 05/14/2018
Labeler — Tianjin Tianyao Pharmaceuticals Co., Ltd. (654534197)
Establishment
Name Address ID/FEI Operations
Tianjin Kingyork Pharmaceuticals Co., Ltd. 544518503 MANUFACTURE (57582-101)

Revised: 04/2022 Tianjin Tianyao Pharmaceuticals Co., Ltd.

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