FDA.reportPublic FDA data

MethylPREDNISolone

Product NDC
0603-4593
11-digit product format
006034593
Labeler code
0603
Product ID
0603-4593_6b210f06-32c0-450a-ad2b-2d0827b06f7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040183
Marketing category
ANDA
Marketing start
1998-12-22
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MethylPREDNISolone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui259966, 762675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-4593-15MethylPREDNISolone21 in 1 DOSE PACKTABLET2124
0603-4593-15MethylPREDNISolone1 in 1 CARTONTABLET124
0603-4593-21MethylPREDNISolone100 in 1 BOTTLE, PLASTICTABLET10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-4593-15EA - Each0603-45933be861db-2ab5-4d6d-827c-8b15d119618212012-07-24
0603-4593-21EA - Each0603-459339b30cb3-2a14-43b0-ada5-c3968d729e9a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [QUALITEST PHARMACEUTICALS]11
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [QUALITEST PHARMACEUTICALS]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [QUALITEST PHARMACEUTICALS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [QUALITEST PHARMACEUTICALS]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [QUALITEST PHARMACEUTICALS]11
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [DISPENSING SOLUTIONS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-4593METHYLPREDNISOLONE TABLET [ENDO USA, INC.]24Current NDC, Legacy NDC, 3 package rows20250112_c84cf5e6-746d-41fb-b3d8-2c0b8ba989af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK56c24076-3d5e-4235-a787-ec6329497084106
259966methylPREDNISolone 4 MG Oral TabletPSN01f0126c-da22-4ac0-8755-3bc589602e6a106
259966methylPREDNISolone 4 MG Oral TabletPSN56c24076-3d5e-4235-a787-ec6329497084106
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN56c24076-3d5e-4235-a787-ec6329497084106
259966methylprednisolone 4 MG Oral TabletSCD01f0126c-da22-4ac0-8755-3bc589602e6a106
259966methylprednisolone 4 MG Oral TabletSCD56c24076-3d5e-4235-a787-ec6329497084106
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY56c24076-3d5e-4235-a787-ec6329497084106
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
259966methylPREDNISolone 4 MG Oral TabletPSNcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
259966methylprednisolone 4 MG Oral TabletSCDcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKc84cf5e6-746d-41fb-b3d8-2c0b8ba989af24
259966methylPREDNISolone 4 MG Oral TabletPSNa14c4f76-6dd5-4c84-b6e5-e5abf19ab55924
259966methylPREDNISolone 4 MG Oral TabletPSNc84cf5e6-746d-41fb-b3d8-2c0b8ba989af24
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNc84cf5e6-746d-41fb-b3d8-2c0b8ba989af24
259966methylprednisolone 4 MG Oral TabletSCDa14c4f76-6dd5-4c84-b6e5-e5abf19ab55924
259966methylprednisolone 4 MG Oral TabletSCDc84cf5e6-746d-41fb-b3d8-2c0b8ba989af24
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYc84cf5e6-746d-41fb-b3d8-2c0b8ba989af24
259966methylPREDNISolone 4 MG Oral TabletPSN97256c7e-5694-4148-926f-594b9d5c34f410
259966methylprednisolone 4 MG Oral TabletSCD97256c7e-5694-4148-926f-594b9d5c34f410
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
259966methylPREDNISolone 4 MG Oral TabletPSN2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
259966methylprednisolone 4 MG Oral TabletSCD2eb5d8c3-87dd-47dc-9619-461dfb7ba9352
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY2eb5d8c3-87dd-47dc-9619-461dfb7ba9352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-4593-15006034593151 DOSE PACK in 1 CARTON (0603-4593-15) / 21 TABLET in 1 DOSE PACK1 dose pack1998-12-220000-00-00NoNoCurrent
0603-4593-2100603459321100 TABLET in 1 BOTTLE, PLASTIC (0603-4593-21) 100 tablet1998-12-220000-00-00NoNoCurrent