Prednisone

Product NDC
62135-553
11-digit product format
621350553
Labeler code
62135
Product ID
62135-553_04b754a5-5740-f71c-e063-6294a90aef67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA084275
Marketing category
ANDA
Marketing start
1974-06-27
Substance
PREDNISONE
Active strength
20 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
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

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
62135-553-30Prednisone30 in 1 BOTTLETABLET301
62135-553-90Prednisone90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-553PREDNISONE TABLET [CHARTWELL RX, LLC]1Current NDC, 2 package rows20230908_92483276-d55c-42c6-8bbc-27137ff25296.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN92483276-d55c-42c6-8bbc-27137ff252961
312615prednisone 20 MG Oral TabletSCD92483276-d55c-42c6-8bbc-27137ff252961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-553-306213505533030 TABLET in 1 BOTTLE (62135-553-30) 30 tablet2023-09-05NoNoHistorical
62135-553-906213505539090 TABLET in 1 BOTTLE (62135-553-90) 90 tablet2023-09-05NoNoHistorical