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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040183-001METHYLPREDNISOLONEMETHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040183-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-223f01610625f2…
2019-09-15 20:21 UTC2019-09A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22b00525d2431f…
2019-07-19 19:46 UTC2019-07A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040183-001METHYLPREDNISOLONE4MGTABLET / ORALAB1998-12-22cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040183-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040183-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040183-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040183-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040183-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040183-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040183-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040183-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040183-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040183-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040183-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040183-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040183-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040183-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040183-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040183-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040183-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040183-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040183-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040183-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040183-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040183-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040183-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040183-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040183-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040183-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040183-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040183-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040183-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040183-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040183-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040183-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040183-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040183-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040183-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040183-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040183-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040183-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040183-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040183-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
MethylPREDNISolone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4W7ZR7023Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259966Internal RxNorm lookup
762675Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c84cf5e6-746d-41fb-b3d8-2c0b8ba989afAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethylprednisoloneMETHYLPREDNISOLONEAmerican Health Packaging97256c7e-5694-4148-926f-594b9d5c34f42026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183
MethylPREDNISoloneMETHYLPREDNISOLONEPar Health USA, LLCc84cf5e6-746d-41fb-b3d8-2c0b8ba989af2026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183
ndc (product): 0603-4593
MethylPREDNISoloneMETHYLPREDNISOLONEPD-Rx Pharmaceuticals, Inc.a14c4f76-6dd5-4c84-b6e5-e5abf19ab5592025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepack01f0126c-da22-4ac0-8755-3bc589602e6a2024-04-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepackcbe5f72a-b0fb-4abb-abfe-2f917d351a002023-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183
MethylPREDNISoloneMETHYLPREDNISOLONEBryant Ranch Prepack56c24076-3d5e-4235-a787-ec63294970842023-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040183
application number: ANDA040183

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