FDA.reportPublic FDA data

Medroloan SUIK

Product NDC
76420-260
Requested package NDC
76420-260-01
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 76420-260-01
ndc (product): 76420-260
ndc11 (package): 76420026001

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

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