Methylprednisolone

Product NDC
59746-001
Requested package NDC
59746-001-06
11-digit product format
597460001
Labeler code
59746
Product ID
59746-001_f7ee0424-d881-4ae1-98be-e8863a8f78fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
JUBILANT CADISTA PHARMACEUTICALS INC.
Application
ANDA040189
Marketing category
ANDA
Marketing start
1997-10-31
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59746-00159746-001-06DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage59746-00159746-001-06IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59746-00159746-001-06IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040189-001METHYLPREDNISOLONEMETHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31
A040189-002METHYLPREDNISOLONEMETHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31
A040189-003METHYLPREDNISOLONEMETHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20
A040189-004METHYLPREDNISOLONEMETHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A040189-001AB
A040189-002AB
A040189-003AB
A040189-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040189-001METHYLPREDNISOLONE4MGTABLET / ORALAB1997-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-002METHYLPREDNISOLONE8MGTABLET / ORALAB1997-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-003METHYLPREDNISOLONE16MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-004METHYLPREDNISOLONE32MGTABLET / ORALAB2007-07-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040189-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040189-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040189-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040189-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040189-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040189-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040189-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040189-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040189-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040189-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040189-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040189-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040189-004AB1d06236e962d9…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-001-032025-07-29C16284748780-13b156c62-249f-fb37-e063-e6dba90a4e07METHYLPREDNISOLONE TABLETS, USP Rx Only
59746-001-062025-07-29C16284748780-13b156c62-249f-fb37-e063-e6dba90a4e07METHYLPREDNISOLONE TABLETS, USP Rx Only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-001-03EA - Each59746-00111c50dea-50fe-4dfe-a860-4811201b44d012012-07-24
59746-001-06EA - Each59746-001b16b37cb-e7e6-4e93-a52e-cf21b044783312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
methylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3552
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]4
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [UNIT DOSE SERVICES]2
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [DIRECT RX]1
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
methylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [DIRECT RX]1
MethylprednisoloneACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [DIRECT RX]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [DIRECT RX]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [STAT RX USA LLC]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [PREFERRED PHARMACEUTICALS, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-001METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [JUBILANT CADISTA PHARMACEUTICALS INC.]7Legacy NDC20240526_7bf4d3d3-3f8a-4e20-9194-061658efca61.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f3676-856f-e8d7-e053-2995a90ad7032024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040189
application number: ANDA040189
MethylprednisoloneMETHYLPREDNISOLONEA-S Medication Solutionseb479561-142d-410c-84b2-988375c6a96e2024-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040189
application number: ANDA040189
MethylprednisoloneMETHYLPREDNISOLONEProficient Rx LP283a913e-f737-478e-b6a0-e050fb6562d82023-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040189
application number: ANDA040189
MethylprednisoloneMETHYLPREDNISOLONEAsclemed USA, Inc.8bfdc471-54f7-4298-ba2f-e5c1f6c484562022-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040189
application number: ANDA040189

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKeb479561-142d-410c-84b2-988375c6a96e9
259966methylPREDNISolone 4 MG Oral TabletPSNeb479561-142d-410c-84b2-988375c6a96e9
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNeb479561-142d-410c-84b2-988375c6a96e9
259966methylprednisolone 4 MG Oral TabletSCDeb479561-142d-410c-84b2-988375c6a96e9
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYeb479561-142d-410c-84b2-988375c6a96e9
259966methylPREDNISolone 4 MG Oral TabletPSN5f2c7b9d-8d0f-46f3-973c-236596bda4c76
259966methylprednisolone 4 MG Oral TabletSCD5f2c7b9d-8d0f-46f3-973c-236596bda4c76
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKbc43521a-d074-4845-91f8-4085e96bf6855
259966methylPREDNISolone 4 MG Oral TabletPSNbc43521a-d074-4845-91f8-4085e96bf6855
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNbc43521a-d074-4845-91f8-4085e96bf6855
259966methylprednisolone 4 MG Oral TabletSCDbc43521a-d074-4845-91f8-4085e96bf6855
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYbc43521a-d074-4845-91f8-4085e96bf6855
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK94e61fbd-8518-4179-bf83-5aa1ea54acfe4
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK283a913e-f737-478e-b6a0-e050fb6562d84
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylPREDNISolone 4 MG Oral TabletPSN694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylPREDNISolone 4 MG Oral TabletPSN283a913e-f737-478e-b6a0-e050fb6562d84
259966methylPREDNISolone 4 MG Oral TabletPSN94e61fbd-8518-4179-bf83-5aa1ea54acfe4
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN94e61fbd-8518-4179-bf83-5aa1ea54acfe4
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN283a913e-f737-478e-b6a0-e050fb6562d84
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylprednisolone 4 MG Oral TabletSCD694cc762-834a-4dd8-9757-eeead4e2e5534
259966methylprednisolone 4 MG Oral TabletSCD283a913e-f737-478e-b6a0-e050fb6562d84
259966methylprednisolone 4 MG Oral TabletSCD94e61fbd-8518-4179-bf83-5aa1ea54acfe4
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY283a913e-f737-478e-b6a0-e050fb6562d84
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY694cc762-834a-4dd8-9757-eeead4e2e5534
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY94e61fbd-8518-4179-bf83-5aa1ea54acfe4
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKf19f3676-856f-e8d7-e053-2995a90ad7033
259966methylPREDNISolone 4 MG Oral TabletPSNf19f3676-856f-e8d7-e053-2995a90ad7033
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNf19f3676-856f-e8d7-e053-2995a90ad7033
259966methylprednisolone 4 MG Oral TabletSCDf19f3676-856f-e8d7-e053-2995a90ad7033
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYf19f3676-856f-e8d7-e053-2995a90ad7033
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKb3139a6a-e9dd-4aeb-9d69-ed98941cf28e2
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK8bfdc471-54f7-4298-ba2f-e5c1f6c484562
259966methylPREDNISolone 4 MG Oral TabletPSN8bfdc471-54f7-4298-ba2f-e5c1f6c484562
259966methylPREDNISolone 4 MG Oral TabletPSNb3139a6a-e9dd-4aeb-9d69-ed98941cf28e2
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNb3139a6a-e9dd-4aeb-9d69-ed98941cf28e2
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN8bfdc471-54f7-4298-ba2f-e5c1f6c484562
259966methylprednisolone 4 MG Oral TabletSCDb3139a6a-e9dd-4aeb-9d69-ed98941cf28e2
259966methylprednisolone 4 MG Oral TabletSCD8bfdc471-54f7-4298-ba2f-e5c1f6c484562
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY8bfdc471-54f7-4298-ba2f-e5c1f6c484562
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYb3139a6a-e9dd-4aeb-9d69-ed98941cf28e2
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKca9d4476-f81b-4a13-a343-88c43cbbcd341
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK0d807b7a-2942-4b13-b3c5-a585ff56fe321
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK2d7c3b1f-d60e-43f3-8d7d-fb0cd60363501
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK6beebbfd-4846-49ec-8f5b-62e2c23c468c1
259966methylPREDNISolone 4 MG Oral TabletPSN0d807b7a-2942-4b13-b3c5-a585ff56fe321
259966methylPREDNISolone 4 MG Oral TabletPSN237c32a4-e029-2541-e063-6394a90af1221
259966methylPREDNISolone 4 MG Oral TabletPSN2d7c3b1f-d60e-43f3-8d7d-fb0cd60363501
259966methylPREDNISolone 4 MG Oral TabletPSN72046304-3203-9043-e053-2995a90a57ea1
259966methylPREDNISolone 4 MG Oral TabletPSNca9d4476-f81b-4a13-a343-88c43cbbcd341
259966methylPREDNISolone 4 MG Oral TabletPSN6beebbfd-4846-49ec-8f5b-62e2c23c468c1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN2d7c3b1f-d60e-43f3-8d7d-fb0cd60363501
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN0d807b7a-2942-4b13-b3c5-a585ff56fe321
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNca9d4476-f81b-4a13-a343-88c43cbbcd341
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN6beebbfd-4846-49ec-8f5b-62e2c23c468c1
259966methylprednisolone 4 MG Oral TabletSCD0d807b7a-2942-4b13-b3c5-a585ff56fe321
259966methylprednisolone 4 MG Oral TabletSCD2d7c3b1f-d60e-43f3-8d7d-fb0cd60363501
259966methylprednisolone 4 MG Oral TabletSCDca9d4476-f81b-4a13-a343-88c43cbbcd341
259966methylprednisolone 4 MG Oral TabletSCD237c32a4-e029-2541-e063-6394a90af1221
259966methylprednisolone 4 MG Oral TabletSCD72046304-3203-9043-e053-2995a90a57ea1
259966methylprednisolone 4 MG Oral TabletSCD6beebbfd-4846-49ec-8f5b-62e2c23c468c1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYca9d4476-f81b-4a13-a343-88c43cbbcd341
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY2d7c3b1f-d60e-43f3-8d7d-fb0cd60363501
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY6beebbfd-4846-49ec-8f5b-62e2c23c468c1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY0d807b7a-2942-4b13-b3c5-a585ff56fe321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-001-0659746000106100 TABLET in 1 BOTTLE (59746-001-06) 100 tablet1997-10-310000-00-00NoNoCurrent