Prednisone

Product NDC
10135-779
11-digit product format
101350779
Labeler code
10135
Product ID
10135-779_441fcae7-8682-1a29-e063-6394a90a3881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2023-02-01
Substance
PREDNISONE
Active strength
50 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
Prednisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 198146, 198148, 312615, 312617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-779-01Prednisone100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-779PREDNISONE TABLET [MARLEX PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20241018_f499197b-b9b7-1707-e053-2a95a90a0932.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198146predniSONE 2.5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312615predniSONE 20 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312617predniSONE 5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198148predniSONE 50 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198145prednisone 10 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198146prednisone 2.5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312615prednisone 20 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312617prednisone 5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198148prednisone 50 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10135-779-0110135077901100 TABLET in 1 BOTTLE (10135-779-01) 100 tablet2023-02-01NoNoCurrent