FDA.reportPublic FDA data

Methylprednisolone

Product NDC
68071-2370
11-digit product format
680712370
Labeler code
68071
Product ID
68071-2370_4b45622d-5003-33a3-e063-6394a90afb6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA011153
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-10-11
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui259966

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
68071-2370-12025-01-14C16284748780-1f386c64a-1670-0266-e053-dadaa90a7c1aMethylprednisolone Tablets, USP
68071-2370-12023-01-30C16284748780-1f386c64a-1670-0266-e053-dadaa90a7c1aMethylprednisolone Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2370-1Methylprednisolone21 in 1 DOSE PACKTABLET213
68071-2370-1Methylprednisolone1 in 1 CARTONTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2370METHYLPREDNISOLONE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20250116_bdd233d9-333d-7389-e053-2a95a90a4b42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259966methylPREDNISolone 4 MG Oral TabletPSNbdd233d9-333d-7389-e053-2a95a90a4b423
259966methylprednisolone 4 MG Oral TabletSCDbdd233d9-333d-7389-e053-2a95a90a4b423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2370-1680712370011 DOSE PACK in 1 CARTON (68071-2370-1) / 21 TABLET in 1 DOSE PACK1 dose pack2021-03-180000-00-00NoNoCurrent