FDA.reportPublic FDA data

METHYLPREDNISOLONE ACETATE

Product NDC
42023-239
11-digit product format
420230239
Labeler code
42023
Product ID
42023-239_9d6bd79b-4885-454e-b127-c5978e501024
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE ACETATE
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Endo USA, Inc.
Application
ANDA214297
Marketing category
ANDA
Marketing start
2023-05-12
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 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 ACETATE40 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
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
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-239-01METHYLPREDNISOLONE ACETATE10 mL in 1 VIALINJECTION, SUSPENSION1019
42023-239-01METHYLPREDNISOLONE ACETATE1 in 1 CARTONINJECTION, SUSPENSION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-239-01ML - Milliliter42023-239a7646489-a3ab-4650-b419-f45656d17aa412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-239METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [ENDO USA, INC.]16Current NDC, 2 package rows20240913_631f7d3e-5620-4be3-b918-2f0d38a97890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSN631f7d3e-5620-4be3-b918-2f0d38a9789019
1358617methylPREDNISolone acetate 80 MG/ML Injectable SuspensionPSN631f7d3e-5620-4be3-b918-2f0d38a9789019
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCD631f7d3e-5620-4be3-b918-2f0d38a9789019
1358617methylprednisolone acetate 80 MG/ML Injectable SuspensionSCD631f7d3e-5620-4be3-b918-2f0d38a9789019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42023-239-01420230239011 VIAL in 1 CARTON (42023-239-01) / 10 mL in 1 VIAL1 vial2023-05-12NoNoHistorical