FDA.reportPublic FDA data

Medroloan SUIK

Product NDC
76420-260
11-digit product format
764200260
Labeler code
76420
Product ID
76420-260_efecfdf4-cb57-34bb-e053-2995a90a37a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2016-06-29
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
Medroloan SUIK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE ACETATE40 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
43502P7F0PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7867127f-aab1-494f-8c3d-e521ed578c3aAvailable on FDA.report

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
76420-260-01Medroloan SUIK1 in 1 CARTONINJECTION, SUSPENSION18
76420-260-01Medroloan SUIK1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SUSPENSION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-260-01EA - Each76420-260dbb8ec4f-a63d-487c-8e94-f72773b48c0d12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-260MEDROLOAN SUIK (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [ASCLEMED USA, INC.]8Current NDC, Legacy NDC, 2 package rows20221222_7867127f-aab1-494f-8c3d-e521ed578c3a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroloan SUIKMETHYLPREDNISOLONE ACETATEAsclemed USA, Inc.7867127f-aab1-494f-8c3d-e521ed578c3a2022-12-09Warnings, Adverse reactionsExact identifier
ndc (product): 76420-260

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-260-01764200260011 VIAL, SINGLE-DOSE in 1 CARTON (76420-260-01) / 1 mL in 1 VIAL, SINGLE-DOSE2016-06-290000-00-00NoNoCurrent