Methylprednisolone Acetate

Product NDC
53217-132
11-digit product format
532170132
Labeler code
53217
Product ID
53217-132_4aad8c0c-47ef-4049-a27e-0f37acdc6be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylprednisolone Acetate
Dosage form
INJECTION, SUSPENSION
Route
INTRALESIONAL; INTRAMUSCULAR; INTRASYNOVIAL; SOFT TISSUE
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA040620
Marketing category
ANDA
Marketing start
2006-10-31
Marketing end
0000-00-00
Substance
METHYLPREDNISOLONE ACETATE
Active strength
40 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-132-012020-01-31C16284748780-19d75b9d0-4c69-f424-e053-dadaa90a57ceMethylprednisolone Acetate Injectable Suspension USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-132-01Methylprednisolone Acetate5 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-132-01ML - Milliliter53217-13240c0959e-e86a-42c7-b96b-75f56eb5697512016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-132METHYLPREDNISOLONE ACETATE INJECTION, SUSPENSION [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 1 package rows20160718_f626db84-9cd2-4005-8182-e2150a5a925d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358610methylPREDNISolone acetate 40 MG/ML Injectable SuspensionPSNf626db84-9cd2-4005-8182-e2150a5a925d3
1358610methylprednisolone acetate 40 MG/ML Injectable SuspensionSCDf626db84-9cd2-4005-8182-e2150a5a925d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53217-132-01532170132015 mL in 1 VIAL, MULTI-DOSE5 mlHistorical