FDA.reportPublic FDA data

METHYLPREDNISOLONE

Product NDC
70518-2864
11-digit product format
705182864
Labeler code
70518
Product ID
70518-2864_4ab9a399-aea8-6c5a-e063-6294a90aa134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204072
Marketing category
ANDA
Marketing start
2020-08-28
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
70518-2864-02023-09-08C16284748780-1d6a99b39-7a45-a426-e053-dadaa90af4c2Methylprednisolone tablets, USP
70518-2864-02023-09-08C16284748780-1d6a99b39-7a45-a426-e053-dadaa90af4c2Methylprednisolone tablets, USP
70518-2864-02022-01-28C16284748780-1d6a99b39-7a45-a426-e053-dadaa90af4c2Methylprednisolone tablets, USP
70518-2864-02022-01-28C16284748780-1d6a99b39-7a45-a426-e053-dadaa90af4c2Methylprednisolone tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2864-0METHYLPREDNISOLONE1 in 1 CARTONTABLET18
70518-2864-0METHYLPREDNISOLONE21 in 1 BLISTER PACKTABLET218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2864-0EA - Each70518-28646b94608c-a27c-4c13-a1e7-434e812c67f312026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2864METHYLPREDNISOLONE TABLET [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20250406_445e59a6-8886-48e7-8116-253a82144934.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK445e59a6-8886-48e7-8116-253a821449348
259966methylPREDNISolone 4 MG Oral TabletPSN445e59a6-8886-48e7-8116-253a821449348
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN445e59a6-8886-48e7-8116-253a821449348
259966methylprednisolone 4 MG Oral TabletSCD445e59a6-8886-48e7-8116-253a821449348
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY445e59a6-8886-48e7-8116-253a821449348

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2864-0705182864001 BLISTER PACK in 1 CARTON (70518-2864-0) / 21 TABLET in 1 BLISTER PACK1 blister pack2020-08-280000-00-00NoNoCurrent