methylprednisolone

Product NDC
70771-1349
11-digit product format
707711349
Labeler code
70771
Product ID
70771-1349_99239c7c-b107-454a-8cee-9dd6cbd5647b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylprednisolone
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206751
Marketing category
ANDA
Marketing start
2018-05-01
Substance
METHYLPREDNISOLONE
Active strength
8 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
METHYLPREDNISOLONE8 mg/1

Harmonized Identifiers#

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

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
70771-1349-1methylprednisolone100 in 1 BOTTLETABLET1008
70771-1349-2methylprednisolone10 in 1 BLISTER PACKTABLET108
70771-1349-4methylprednisolone10 in 1 CARTONTABLET108
70771-1349-5methylprednisolone500 in 1 BOTTLETABLET5008
70771-1349-8methylprednisolone25 in 1 BOTTLETABLET258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1349METHYLPREDNISOLONE TABLET [ZYDUS LIFESCIENCES LIMITED]8Current NDC, Legacy NDC, 5 package rows20241207_fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
328161methylPREDNISolone 16 MG Oral TabletPSNfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
197971methylPREDNISolone 32 MG Oral TabletPSNfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
259966methylPREDNISolone 4 MG Oral TabletPSNfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
197973methylPREDNISolone 8 MG Oral TabletPSNfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
328161methylprednisolone 16 MG Oral TabletSCDfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
197971methylprednisolone 32 MG Oral TabletSCDfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
259966methylprednisolone 4 MG Oral TabletSCDfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8
197973methylprednisolone 8 MG Oral TabletSCDfe9c15b5-4264-45f1-87b5-f7e1d6e6ddee8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1349-170771134901100 TABLET in 1 BOTTLE (70771-1349-1) 100 tablet2018-05-010000-00-00NoNoCurrent
70771-1349-27077113490210 in 1 BLISTER PACKHistorical
70771-1349-47077113490410 BLISTER PACK in 1 CARTON (70771-1349-4) / 10 TABLET in 1 BLISTER PACK (70771-1349-2) 10 blister pack2018-05-010000-00-00NoNoCurrent
70771-1349-570771134905500 TABLET in 1 BOTTLE (70771-1349-5) 500 tablet2018-05-010000-00-00NoNoCurrent
70771-1349-87077113490825 TABLET in 1 BOTTLE (70771-1349-8) 25 tablet2018-05-010000-00-00NoNoCurrent