FDA.reportPublic FDA data

methylprednisolone

Product NDC
68382-919
11-digit product format
683820919
Labeler code
68382
Product ID
68382-919_6cebff10-362f-41a7-8f66-3d9e878760fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA206751
Marketing category
ANDA
Marketing start
2018-05-01
Substance
METHYLPREDNISOLONE
Active strength
32 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE32 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui197971, 197973, 259966, 328161, 762675

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b3918abe-5cd1-b0ce-abd7-2dd6732cde26Product name520260128
e1637c7c-52c4-49a3-b36b-61be755aab29Product name420230717
9eb3e96d-a1d4-4de3-aa3d-a629eea44815Product name420220316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-919-01methylprednisolone100 in 1 BOTTLETABLET1008
68382-919-05methylprednisolone500 in 1 BOTTLETABLET5008
68382-919-11methylprednisolone25 in 1 BOTTLETABLET258
68382-919-30methylprednisolone10 in 1 BLISTER PACKTABLET108
68382-919-77methylprednisolone10 in 1 CARTONTABLET108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-919-11EA - Each68382-919c518bd19-a420-4ed2-a02a-05d58991797512018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-919METHYLPREDNISOLONE TABLET [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 5 package rows20240701_eaa9c932-c659-4ef6-bf5a-186545d87320.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKeaa9c932-c659-4ef6-bf5a-186545d873208
328161methylPREDNISolone 16 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
197971methylPREDNISolone 32 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
259966methylPREDNISolone 4 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNeaa9c932-c659-4ef6-bf5a-186545d873208
197973methylPREDNISolone 8 MG Oral TabletPSNeaa9c932-c659-4ef6-bf5a-186545d873208
328161methylprednisolone 16 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
197971methylprednisolone 32 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
259966methylprednisolone 4 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
197973methylprednisolone 8 MG Oral TabletSCDeaa9c932-c659-4ef6-bf5a-186545d873208
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYeaa9c932-c659-4ef6-bf5a-186545d873208
197971methylPREDNISolone 32 MG Oral TabletPSN1e1ccb15-0fd1-0739-e063-6394a90a7f681
197971methylprednisolone 32 MG Oral TabletSCD1e1ccb15-0fd1-0739-e063-6394a90a7f681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-919-0168382091901100 TABLET in 1 BOTTLE (68382-919-01) 100 tablet2018-05-010000-00-00NoNoCurrent
68382-919-0568382091905500 TABLET in 1 BOTTLE (68382-919-05) 500 tablet2018-05-010000-00-00NoNoCurrent
68382-919-116838209191125 TABLET in 1 BOTTLE (68382-919-11) 25 tablet2018-05-010000-00-00NoNoCurrent
68382-919-306838209193010 in 1 BLISTER PACKHistorical
68382-919-776838209197710 BLISTER PACK in 1 CARTON (68382-919-77) / 10 TABLET in 1 BLISTER PACK (68382-919-30) 10 blister pack2018-05-010000-00-00NoNoCurrent