METHYLPREDNISOLONE

Product NDC
76420-193
11-digit product format
764200193
Labeler code
76420
Product ID
76420-193_bda4563a-3fa1-a76b-e053-2995a90a304c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPREDNISOLONE
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-193-21METHYLPREDNISOLONE21 in 1 BLISTER PACKTABLET211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-193-21EA - Each76420-193ff819bcc-7976-4188-b2d1-02374f17de5112021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-193METHYLPREDNISOLONE TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 1 package rows20210317_8bff5330-c1f6-4014-aadb-45c1726248dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
762675{21 (methylprednisolone 4 MG Oral Tablet) } PackGPCK8bff5330-c1f6-4014-aadb-45c1726248dd1
259966methylPREDNISolone 4 MG Oral TabletPSN8bff5330-c1f6-4014-aadb-45c1726248dd1
762675methylPREDNISolone 4 MG Tablet 6 Day 21 Count PackPSN8bff5330-c1f6-4014-aadb-45c1726248dd1
259966methylprednisolone 4 MG Oral TabletSCD8bff5330-c1f6-4014-aadb-45c1726248dd1
762675methylprednisolone 4 MG Oral Tablet 21 Count PackSY8bff5330-c1f6-4014-aadb-45c1726248dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-193-217642001932121 TABLET in 1 BLISTER PACK (76420-193-21) 21 tablet2021-03-160000-00-00NoNoCurrent