Methylprednisolone

Product NDC
53002-3120
11-digit product format
530023120
Labeler code
53002
Product ID
53002-3120_d079ff38-b585-4979-910a-e2ea043c0a83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
RPK 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
2021-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3120-1Methylprednisolone21 in 1 BLISTER PACKTABLET216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3120METHYLPREDNISOLONE (METHYLPREDNISOLONE) TABLET [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20230609_5f2c7b9d-8d0f-46f3-973c-236596bda4c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259966methylPREDNISolone 4 MG Oral TabletPSN5f2c7b9d-8d0f-46f3-973c-236596bda4c76
259966methylprednisolone 4 MG Oral TabletSCD5f2c7b9d-8d0f-46f3-973c-236596bda4c76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3120-15300231200121 TABLET in 1 BLISTER PACK (53002-3120-1) 21 tablet2017-10-010000-00-00NoNoCurrent