Methylprednisolone

Product NDC
61919-149
11-digit product format
619190149
Labeler code
61919
Product ID
61919-149_9c98f93b-b7b0-6e41-e053-2a95a90aaff4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA040189
Marketing category
ANDA
Marketing start
2014-01-01
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-149DDiscontinued by firm2026-08-07
excluded packagepackage61919-14961919-149-21DDiscontinued by firm2026-08-07

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-149-21IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-149-21IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-149-21IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-149-21IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-149-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-149-21IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-149-21IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-149-21IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-149-21IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-149-21IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-149-21IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-149-21IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-149-21IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-149-21IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-149-21IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-149-21EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
61919-149-212023-01-30C16284748780-1f386c649-db78-0266-e053-dadaa90a7c1aMethylprednisolone

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-149-21EA - Each61919-1498a85ca1a-ae39-46fb-8536-a6d542e157b012014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethylprednisoloneACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [DIRECT RX]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [DIRECT RX]1
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [DIRECT RX]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [DIRECT RX]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [DIRECT RX]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [DIRECT RX]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [DIRECT RX]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [DIRECT RX]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-149METHYLPREDNISOLONE TABLET [DIRECT RX]6Legacy NDC20200130_56bab96a-3326-4a2c-b051-63e0768e566e.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-149-216191901492121 TABLET in 1 BLISTER PACK (61919-149-21) 21 tablet2014-01-010000-00-00NoNoCurrent