FDA.reportPublic FDA data

Methylprednisolone acetate

Product NDC
85766-031
11-digit product format
857660031
Labeler code
85766
Product ID
85766-031_4a2b73a8-c0f9-85f9-e063-6294a90ac52c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Sportpharm LLC
Application
ANDA210043
Marketing category
ANDA
Marketing start
2019-05-20
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methylprednisolone acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii43502P7F0P
Rxcui1743779

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
85766-031-01Methylprednisolone acetate1 in 1 CARTONINJECTION, SUSPENSION12
85766-031-01Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION12
85766-031-25Methylprednisolone acetate25 in 1 CARTONINJECTION, SUSPENSION252
85766-031-25Methylprednisolone acetate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1743779methylPREDNISolone acetate 40 MG in 1 ML InjectionPSN62f4339a-a971-414d-b407-ef030fe4f9892
17437791 ML methylprednisolone acetate 40 MG/ML InjectionSCD62f4339a-a971-414d-b407-ef030fe4f9892
1743779methylprednisolone acetate 40 MG per 1 ML InjectionSY62f4339a-a971-414d-b407-ef030fe4f9892

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-031-01857660031011 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-08-07NoNoCurrent
85766-031-258576600312525 VIAL, SINGLE-DOSE in 1 CARTON (85766-031-25) / 1 mL in 1 VIAL, SINGLE-DOSE2025-08-07NoNoCurrent