FDA.reportPublic FDA data

MethylPREDNISolone

Product NDC
72162-1161
11-digit product format
721621161
Labeler code
72162
Product ID
72162-1161_ef688580-523e-40e5-b0a5-b92b78b3cbc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040183
Marketing category
ANDA
Marketing start
1998-12-22
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
72162-1161-1MethylPREDNISolone100 in 1 BOTTLE, PLASTICTABLET100100
72162-1161-2MethylPREDNISolone1 in 1 CARTONTABLET1100
72162-1161-2MethylPREDNISolone21 in 1 DOSE PACKTABLET21100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1161-1EA - Each72162-116104064470-0985-4b74-b77b-69f27e7d569a12024-01-04
72162-1161-2EA - Each72162-1161f4eac7b7-eb20-411f-9d23-732a1f4e52b512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1161METHYLPREDNISOLONE TABLET [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20230927_cbe5f72a-b0fb-4abb-abfe-2f917d351a00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
259966methylPREDNISolone 4 MG Oral TabletPSNcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
259966methylprednisolone 4 MG Oral TabletSCDcbe5f72a-b0fb-4abb-abfe-2f917d351a00100
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYcbe5f72a-b0fb-4abb-abfe-2f917d351a00100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1161-172162116101100 TABLET in 1 BOTTLE, PLASTIC (72162-1161-1) 100 tablet2023-09-26NoNoCurrent
72162-1161-2721621161021 DOSE PACK in 1 CARTON (72162-1161-2) / 21 TABLET in 1 DOSE PACK1 dose pack2023-09-26NoNoCurrent