FDA.reportPublic FDA data

methylprednisolone

Product NDC
68382-916
11-digit product format
683820916
Labeler code
68382
Product ID
68382-916_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
4 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
METHYLPREDNISOLONE4 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
68382-916-01methylprednisolone100 in 1 BOTTLETABLET1008
68382-916-05methylprednisolone500 in 1 BOTTLETABLET5008
68382-916-34methylprednisolone1 in 1 CARTONTABLET18
68382-916-34methylprednisolone21 in 1 BLISTER PACKTABLET218

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-916-01EA - Each68382-916d22f8fdf-6765-4430-a8c2-7301968c77e512018-08-13
68382-916-34EA - Each68382-916ee14ea23-565f-4fb1-a1d4-06055925d41912018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-916METHYLPREDNISOLONE TABLET [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 4 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
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylPREDNISolone 4 MG Oral TabletPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylprednisolone 4 MG Oral TabletSCD646bb826-8d5a-4b03-adfb-ed45daa86d447
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY646bb826-8d5a-4b03-adfb-ed45daa86d447
259966methylPREDNISolone 4 MG Oral TabletPSN3885151c-963e-4d22-b5b4-58968503ad8c5
259966methylprednisolone 4 MG Oral TabletSCD3885151c-963e-4d22-b5b4-58968503ad8c5
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylPREDNISolone 4 MG Oral TabletPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNf19f6120-3c25-2a28-e053-2a95a90a86d53
259966methylprednisolone 4 MG Oral TabletSCDf19f6120-3c25-2a28-e053-2a95a90a86d53
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYf19f6120-3c25-2a28-e053-2a95a90a86d53
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylPREDNISolone 4 MG Oral TabletPSNe08ff15a-a457-a71d-e053-2a95a90ae08c1
259966methylPREDNISolone 4 MG Oral TabletPSN177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN177fd649-4339-4bfd-bd12-7e8de302412b1
259966methylprednisolone 4 MG Oral TabletSCDe08ff15a-a457-a71d-e053-2a95a90ae08c1
259966methylprednisolone 4 MG Oral TabletSCD177fd649-4339-4bfd-bd12-7e8de302412b1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY177fd649-4339-4bfd-bd12-7e8de302412b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-916-0168382091601100 TABLET in 1 BOTTLE (68382-916-01) 100 tablet2018-05-010000-00-00NoNoCurrent
68382-916-0568382091605500 TABLET in 1 BOTTLE (68382-916-05) 500 tablet2018-05-010000-00-00NoNoCurrent
68382-916-34683820916341 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK1 blister pack2018-05-010000-00-00NoNoCurrent