FDA.reportPublic FDA data

methylprednisolone

Product NDC
82804-007
11-digit product format
828040007
Labeler code
82804
Product ID
82804-007_177fd649-4339-4bfd-bd12-7e8de302412b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
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
82804-007-21methylprednisolone21 in 1 BOTTLETABLET211
82804-007-30methylprednisolone30 in 1 BOTTLETABLET301
82804-007-60methylprednisolone60 in 1 BOTTLETABLET601
82804-007-90methylprednisolone90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-007METHYLPREDNISOLONE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20230914_177fd649-4339-4bfd-bd12-7e8de302412b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylPREDNISolone 4 MG Oral TabletPSN177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylprednisolone 4 MG Oral TabletSCD177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY177fd649-4339-4bfd-bd12-7e8de302412b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-007-218280400072121 TABLET in 1 BOTTLE (82804-007-21) 21 tablet2023-09-08NoNoCurrent
82804-007-308280400073030 TABLET in 1 BOTTLE (82804-007-30) 30 tablet2023-09-08NoNoCurrent
82804-007-608280400076060 TABLET in 1 BOTTLE (82804-007-60) 60 tablet2023-09-08NoNoCurrent
82804-007-908280400079090 TABLET in 1 BOTTLE (82804-007-90) 90 tablet2023-09-08NoNoCurrent