FDA.reportPublic FDA data

METHYLPREDNISOLONE

Product NDC
42806-400
11-digit product format
428060400
Labeler code
42806
Product ID
42806-400_a7416892-37af-4d45-ab52-5e5700e6b3e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA204072
Marketing category
ANDA
Marketing start
2018-05-14
Substance
METHYLPREDNISOLONE
Active strength
4 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
METHYLPREDNISOLONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYLPREDNISOLONE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4W7ZR7023
Rxcui259966, 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42806-400-012022-08-10C16284748780-1e4f33bdf-9bc7-d8a0-e053-dadaa90a6e4eMethylprednisolone tablets, USP
42806-400-212022-08-10C16284748780-1e4f33bdf-9bc7-d8a0-e053-dadaa90a6e4eMethylprednisolone tablets, USP
42806-400-012022-07-29C16284748780-1e4f33bdf-9bc7-d8a0-e053-dadaa90a6e4eMethylprednisolone tablets, USP
42806-400-212022-07-29C16284748780-1e4f33bdf-9bc7-d8a0-e053-dadaa90a6e4eMethylprednisolone tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-400-01METHYLPREDNISOLONE100 in 1 BOTTLETABLET1009
42806-400-21METHYLPREDNISOLONE21 in 1 BLISTER PACKTABLET219
42806-400-21METHYLPREDNISOLONE1 in 1 CARTONTABLET19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-400-01EA - Each42806-40081e9c4e2-8ab0-4a12-a197-2f6f607b43fa12019-07-02
42806-400-21EA - Each42806-40047f3ac01-c90a-499a-b73e-cc4e1e504e4b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-400METHYLPREDNISOLONE TABLET [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 3 package rows20241016_b1908c2a-c596-4e2a-b2bd-0745d4fea31a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKb1908c2a-c596-4e2a-b2bd-0745d4fea31a9
259966methylPREDNISolone 4 MG Oral TabletPSNb1908c2a-c596-4e2a-b2bd-0745d4fea31a9
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNb1908c2a-c596-4e2a-b2bd-0745d4fea31a9
259966methylprednisolone 4 MG Oral TabletSCDb1908c2a-c596-4e2a-b2bd-0745d4fea31a9
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYb1908c2a-c596-4e2a-b2bd-0745d4fea31a9
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK445e59a6-8886-48e7-8116-253a821449348
259966methylPREDNISolone 4 MG Oral TabletPSN445e59a6-8886-48e7-8116-253a821449348
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN445e59a6-8886-48e7-8116-253a821449348
259966methylprednisolone 4 MG Oral TabletSCD445e59a6-8886-48e7-8116-253a821449348
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY445e59a6-8886-48e7-8116-253a821449348
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKe27ab941-adc6-47b6-b217-08d095a851fd5
259966methylPREDNISolone 4 MG Oral TabletPSNe27ab941-adc6-47b6-b217-08d095a851fd5
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNe27ab941-adc6-47b6-b217-08d095a851fd5
259966methylprednisolone 4 MG Oral TabletSCDe27ab941-adc6-47b6-b217-08d095a851fd5
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYe27ab941-adc6-47b6-b217-08d095a851fd5
259966methylPREDNISolone 4 MG Oral TabletPSNa1dae00d-1ad3-7493-e053-2a95a90af49f4
259966methylprednisolone 4 MG Oral TabletSCDa1dae00d-1ad3-7493-e053-2a95a90af49f4
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKf19f4304-bf37-da04-e053-2a95a90a40443
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK8c3f3f63-8a05-7a4a-e053-2995a90ad95a3
259966methylPREDNISolone 4 MG Oral TabletPSNc6ec50b5-aeb8-40c3-83e2-af4fe8fefb143
259966methylPREDNISolone 4 MG Oral TabletPSNf19f4304-bf37-da04-e053-2a95a90a40443
259966methylPREDNISolone 4 MG Oral TabletPSN8c3f3f63-8a05-7a4a-e053-2995a90ad95a3
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNf19f4304-bf37-da04-e053-2a95a90a40443
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN8c3f3f63-8a05-7a4a-e053-2995a90ad95a3
259966methylprednisolone 4 MG Oral TabletSCDc6ec50b5-aeb8-40c3-83e2-af4fe8fefb143
259966methylprednisolone 4 MG Oral TabletSCDf19f4304-bf37-da04-e053-2a95a90a40443
259966methylprednisolone 4 MG Oral TabletSCD8c3f3f63-8a05-7a4a-e053-2995a90ad95a3
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYf19f4304-bf37-da04-e053-2a95a90a40443
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY8c3f3f63-8a05-7a4a-e053-2995a90ad95a3
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK3e37236f-8ba8-4a1c-87c8-62b787890fae2
259966methylPREDNISolone 4 MG Oral TabletPSN1624c56f-0ea0-4fa8-ba47-013c4b985d8c2
259966methylPREDNISolone 4 MG Oral TabletPSNfd9f28a0-fd86-4767-876c-8520fddeccd22
259966methylPREDNISolone 4 MG Oral TabletPSN3e37236f-8ba8-4a1c-87c8-62b787890fae2
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN3e37236f-8ba8-4a1c-87c8-62b787890fae2
259966methylprednisolone 4 MG Oral TabletSCD1624c56f-0ea0-4fa8-ba47-013c4b985d8c2
259966methylprednisolone 4 MG Oral TabletSCDfd9f28a0-fd86-4767-876c-8520fddeccd22
259966methylprednisolone 4 MG Oral TabletSCD3e37236f-8ba8-4a1c-87c8-62b787890fae2
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY3e37236f-8ba8-4a1c-87c8-62b787890fae2
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK235ca8cf-1576-0dfd-e063-6394a90a8b251
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCKed133143-ffe0-40f0-b8b9-77aa44ff21f51
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK8bff5330-c1f6-4014-aadb-45c1726248dd1
259966methylPREDNISolone 4 MG Oral TabletPSN476ef50d-7e77-75f6-e063-6294a90a26e41
259966methylPREDNISolone 4 MG Oral TabletPSN8bff5330-c1f6-4014-aadb-45c1726248dd1
259966methylPREDNISolone 4 MG Oral TabletPSN1e1cfbe0-fcc8-951e-e063-6394a90a50a21
259966methylPREDNISolone 4 MG Oral TabletPSNed133143-ffe0-40f0-b8b9-77aa44ff21f51
259966methylPREDNISolone 4 MG Oral TabletPSN235ca8cf-1576-0dfd-e063-6394a90a8b251
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN8bff5330-c1f6-4014-aadb-45c1726248dd1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSNed133143-ffe0-40f0-b8b9-77aa44ff21f51
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN235ca8cf-1576-0dfd-e063-6394a90a8b251
259966methylprednisolone 4 MG Oral TabletSCD8bff5330-c1f6-4014-aadb-45c1726248dd1
259966methylprednisolone 4 MG Oral TabletSCD476ef50d-7e77-75f6-e063-6294a90a26e41
259966methylprednisolone 4 MG Oral TabletSCD1e1cfbe0-fcc8-951e-e063-6394a90a50a21
259966methylprednisolone 4 MG Oral TabletSCD235ca8cf-1576-0dfd-e063-6394a90a8b251
259966methylprednisolone 4 MG Oral TabletSCDed133143-ffe0-40f0-b8b9-77aa44ff21f51
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSYed133143-ffe0-40f0-b8b9-77aa44ff21f51
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY8bff5330-c1f6-4014-aadb-45c1726248dd1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY235ca8cf-1576-0dfd-e063-6394a90a8b251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-400-0142806040001100 TABLET in 1 BOTTLE (42806-400-01) 100 tablet2018-05-140000-00-00NoNoCurrent
42806-400-21428060400211 BLISTER PACK in 1 CARTON (42806-400-21) / 21 TABLET in 1 BLISTER PACK1 blister pack2019-02-140000-00-00NoNoCurrent