FDA.reportPublic FDA data

METHYLPREDNISOLONE ACETATE

Product NDC
0781-3516
11-digit product format
007813516
Labeler code
0781
Product ID
0781-3516_ab8910e5-0b8c-4057-a95d-4519ce85835b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Sandoz Inc.
Application
ANDA214870
Marketing category
ANDA
Marketing start
2023-02-08
Substance
METHYLPREDNISOLONE ACETATE
Active strength
80 mg/mL
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 ACETATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1358610, 1358617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3516-75METHYLPREDNISOLONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION17
0781-3516-75METHYLPREDNISOLONE ACETATE5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3516-75ML - Milliliter0781-35161bf54819-729b-4fc1-85da-a495523e34e912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3516METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [SANDOZ INC.]7Current NDC, 2 package rows20240316_a363f0cd-9c8e-4622-9271-171706846b96.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNa363f0cd-9c8e-4622-9271-171706846b967
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSNa363f0cd-9c8e-4622-9271-171706846b967
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDa363f0cd-9c8e-4622-9271-171706846b967
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCDa363f0cd-9c8e-4622-9271-171706846b967

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0781-3516-75007813516751 VIAL, MULTI-DOSE in 1 CARTON (0781-3516-75) / 5 mL in 1 VIAL, MULTI-DOSE2023-02-08NoNoCurrent