Label: METHYLPREDNISOLONE tablet
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NDC Code(s):
70771-1348-1,
70771-1348-3,
70771-1348-5,
70771-1349-1, view more70771-1349-2, 70771-1349-4, 70771-1349-5, 70771-1349-8, 70771-1350-1, 70771-1350-2, 70771-1350-4, 70771-1350-5, 70771-1350-7, 70771-1351-1, 70771-1351-2, 70771-1351-4, 70771-1351-5, 70771-1351-8
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1348-1 in bottle of 100 tablets
Methylprednisolone tablets, USP
Rx only
100 tablets
NDC 70771-1349-8 in bottle of 25 tablets
Methylprednisolone tablets, USP
Rx only
25 tablets
NDC 70771-1350-7 in bottle of 50 tablets
Methylprednisolone tablets, USP
Rx only
50 tablets
NDC 70771-1351-8 in bottle of 25 tablets
Methylprednisolone tablets, USP
Rx only
25 tablets
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INGREDIENTS AND APPEARANCE
METHYLPREDNISOLONE
methylprednisolone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1348 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE 4 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 4 pieces Shape OVAL (OVAL) Size 8mm Flavor Imprint Code 916 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1348-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:70771-1348-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 3 NDC:70771-1348-3 1 in 1 CARTON 05/01/2018 3 21 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206751 05/01/2018 METHYLPREDNISOLONE
methylprednisolone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1349 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE 8 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 10mm Flavor Imprint Code 917 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1349-8 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:70771-1349-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 3 NDC:70771-1349-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 4 NDC:70771-1349-4 10 in 1 CARTON 05/01/2018 4 NDC:70771-1349-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206751 05/01/2018 METHYLPREDNISOLONE
methylprednisolone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1350 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE 16 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 4 pieces Shape OVAL (OVAL) Size 10mm Flavor Imprint Code 918 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1350-7 50 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:70771-1350-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 3 NDC:70771-1350-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 4 NDC:70771-1350-4 10 in 1 CARTON 05/01/2018 4 NDC:70771-1350-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206751 05/01/2018 METHYLPREDNISOLONE
methylprednisolone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1351 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023) METHYLPREDNISOLONE 32 mg Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces Shape OVAL (OVAL) Size 14mm Flavor Imprint Code 919 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1351-8 25 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 2 NDC:70771-1351-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 3 NDC:70771-1351-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/01/2018 4 NDC:70771-1351-4 10 in 1 CARTON 05/01/2018 4 NDC:70771-1351-2 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206751 05/01/2018 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1348, 70771-1349, 70771-1350, 70771-1351) , MANUFACTURE(70771-1348, 70771-1349, 70771-1350, 70771-1351)