Methylprednisolone

Product NDC
70518-4213
11-digit product format
705184213
Labeler code
70518
Product ID
70518-4213_3ff680c9-1eea-146b-e063-6394a90a7fa7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA011153
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-10-14
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4213-0Methylprednisolone1 in 1 CARTONTABLET14
70518-4213-0Methylprednisolone21 in 1 DOSE PACKTABLET214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4213METHYLPREDNISOLONE TABLET [REMEDYREPACK INC.]3Current NDC, 2 package rows20241213_d2a0e52c-f724-40e6-9d2a-5f1487c104b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKd2a0e52c-f724-40e6-9d2a-5f1487c104b64
259966methylPREDNISolone 4 MG Oral TabletPSNd2a0e52c-f724-40e6-9d2a-5f1487c104b64
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNd2a0e52c-f724-40e6-9d2a-5f1487c104b64
259966methylprednisolone 4 MG Oral TabletSCDd2a0e52c-f724-40e6-9d2a-5f1487c104b64
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYd2a0e52c-f724-40e6-9d2a-5f1487c104b64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4213-0705184213001 DOSE PACK in 1 CARTON (70518-4213-0) / 21 TABLET in 1 DOSE PACK1 dose pack2024-10-14NoNoHistorical