FDA.reportPublic FDA data

methylprednisolone

Product NDC
50090-3811
11-digit product format
500903811
Labeler code
50090
Product ID
50090-3811_6bfd8b00-0c6c-40cb-b0dc-677d8d0d0563
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206751
Marketing category
ANDA
Marketing start
2018-05-01
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, 762675

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
50090-3811-02024-10-22C16284748780-1f386c64a-0fda-0266-e053-dadaa90a7c1aMETHYLPREDNISOLONE TABLETS, USP
50090-3811-02023-01-30C16284748780-1f386c64a-0fda-0266-e053-dadaa90a7c1aMETHYLPREDNISOLONE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3811-0methylprednisolone21 in 1 BLISTER PACKTABLET217
50090-3811-0methylprednisolone1 in 1 CARTONTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3811-0EA - Each50090-38116cdccb32-0faf-4d43-aeb5-6df889224e4612021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3811METHYLPREDNISOLONE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20241024_646bb826-8d5a-4b03-adfb-ed45daa86d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylPREDNISolone 4 MG Oral TabletPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylprednisolone 4 MG Oral TabletSCD646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY646bb826-8d5a-4b03-adfb-ed45daa86d447

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3811-0500903811001 BLISTER PACK in 1 CARTON (50090-3811-0) / 21 TABLET in 1 BLISTER PACK1 blister pack2018-11-120000-00-00NoNoCurrent