Methylprednisolone

Product NDC
80425-0231
11-digit product format
804250231
Labeler code
80425
Product ID
80425-0231_2a9aec09-6307-2252-e063-6294a90a204a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA206751
Marketing category
ANDA
Marketing start
2023-01-11
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
80425-0231-1Methylprednisolone1 in 1 CARTONTABLET13
80425-0231-1Methylprednisolone21 in 1 BLISTER PACKTABLET213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0231-1EA - Each80425-0231f7a54d7f-e2ea-4100-8f0e-0f27c3aa3f3b12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0231METHYLPREDNISOLONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 2 package rows20250102_f19f6120-3c25-2a28-e053-2a95a90a86d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylPREDNISolone 4 MG Oral TabletPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylprednisolone 4 MG Oral TabletSCDf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYf19f6120-3c25-2a28-e053-2a95a90a86d53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0231-1804250231011 BLISTER PACK in 1 CARTON (80425-0231-1) / 21 TABLET in 1 BLISTER PACK1 blister pack2023-01-11NoNoCurrent