methylprednisolone

Product NDC
68071-2745
11-digit product format
680712745
Labeler code
68071
Product ID
68071-2745_e08ff660-d8d7-7a39-e053-2a95a90ac910
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206751
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct68071-2745IInactivated by FDA2026-08-07
excluded packagepackage68071-274568071-2745-1IInactivated by FDA2026-08-07

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 · 18 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 packagepackage68071-2745-1IInactivated 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 packagepackage68071-2745-1IInactivated 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 packagepackage68071-2745-1IInactivated 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 packagepackage68071-2745-1IInactivated 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 packagepackage68071-2745-1IInactivated 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 packagepackage68071-2745-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2745-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2745-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2745-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A206751-001METHYLPREDNISOLONEMETHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23
A206751-002METHYLPREDNISOLONEMETHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23
A206751-003METHYLPREDNISOLONEMETHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23
A206751-004METHYLPREDNISOLONEMETHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206751-001AB
A206751-002AB
A206751-003AB
A206751-004AB

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 UTC2026-02A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206751-001METHYLPREDNISOLONE4MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-002METHYLPREDNISOLONE8MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-003METHYLPREDNISOLONE16MGTABLET / ORALAB2018-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-004METHYLPREDNISOLONE32MGTABLET / ORALAB2018-04-23d06236e962d9…

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 UTC2026-02A206751-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206751-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206751-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206751-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206751-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206751-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206751-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206751-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206751-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206751-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206751-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206751-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206751-004AB1d06236e962d9…

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
68071-2745-12025-01-30C16284748780-12cef2736-82fb-d83d-e063-dadaa90ab31fMETHYLPREDNISOLONE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2745-1methylprednisolone21 in 1 BLISTER PACKTABLET211
68071-2745-1methylprednisolone1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2745METHYLPREDNISOLONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220604_e08ff15a-a457-a71d-e053-2a95a90ae08c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
methylprednisoloneMETHYLPREDNISOLONEBluePoint Laboratories7092df48-4904-4047-9916-e585417a216f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEA-S Medication Solutions646bb826-8d5a-4b03-adfb-ed45daa86d442026-03-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEMajor Pharmaceuticals3885151c-963e-4d22-b5b4-58968503ad8c2025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEZydus Pharmaceuticals USA Inc.eaa9c932-c659-4ef6-bf5a-186545d873202025-11-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
MethylprednisoloneMETHYLPREDNISOLONEAdvanced Rx Pharmacy of Tennessee, LLCf19f6120-3c25-2a28-e053-2a95a90a86d52024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEZydus Lifesciences Limitedfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee2024-12-05Exact identifier
application applno (ANDA): 206751
application number: ANDA206751
methylprednisoloneMETHYLPREDNISOLONEProficient Rx LP177fd649-4339-4bfd-bd12-7e8de302412b2023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206751
application number: ANDA206751

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259966methylPREDNISolone 4 MG Oral TabletPSNe08ff15a-a457-a71d-e053-2a95a90ae08c1
259966methylprednisolone 4 MG Oral TabletSCDe08ff15a-a457-a71d-e053-2a95a90ae08c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2745-1680712745011 BLISTER PACK in 1 CARTON (68071-2745-1) > 21 TABLET in 1 BLISTER PACK1 blister pack2022-06-030000-00-00NoNoCurrent