FDA.reportPublic FDA data

Methylprednisolone

Product NDC
33261-335
11-digit product format
332610335
Labeler code
33261
Product ID
33261-335_09135c69-fdaa-4452-a8d4-81cff1a36ceb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-335-212020-01-31C16284748780-19d75b9d1-24c9-f424-e053-dadaa90a57ceMETHYLPREDNISOLONE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-335-21Methylprednisolone21 in 1 BLISTER PACKTABLET211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-335-21EA - Each33261-335a7b98160-fcae-4fbf-9101-2a37c92bee0612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHYLPREDNISOLONEACTIVE INGREDIENTX4W7ZR7023METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
METHYLPREDNISOLONEACTIVE MOIETYX4W7ZR7023METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-335METHYLPREDNISOLONE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140128_ca9d4476-f81b-4a13-a343-88c43cbbcd34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKca9d4476-f81b-4a13-a343-88c43cbbcd341
259966methylPREDNISolone 4 MG Oral TabletPSNca9d4476-f81b-4a13-a343-88c43cbbcd341
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNca9d4476-f81b-4a13-a343-88c43cbbcd341
259966methylprednisolone 4 MG Oral TabletSCDca9d4476-f81b-4a13-a343-88c43cbbcd341
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYca9d4476-f81b-4a13-a343-88c43cbbcd341

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-335-213326103352121 in 1 BLISTER PACKHistorical