FDA.reportPublic FDA data

Prednisone

Product NDC
68071-3617
11-digit product format
680713617
Labeler code
68071
Product ID
68071-3617_266c8cce-cdc9-557d-e063-6394a90a9bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
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
68071-3617-1Prednisone10 in 1 BOTTLETABLET105
68071-3617-4Prednisone14 in 1 BOTTLETABLET145
68071-3617-6Prednisone60 in 1 BOTTLETABLET605
68071-3617-7Prednisone21 in 1 BOTTLETABLET215
68071-3617-8Prednisone8 in 1 BOTTLETABLET85

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3617PREDNISONE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, 5 package rows20241109_1b42449a-2be8-e4fb-e063-6394a90aff98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN1b42449a-2be8-e4fb-e063-6394a90aff985
312615prednisone 20 MG Oral TabletSCD1b42449a-2be8-e4fb-e063-6394a90aff985

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3617-16807136170110 TABLET in 1 BOTTLE (68071-3617-1) 10 tablet2024-06-19NoNoHistorical
68071-3617-46807136170414 TABLET in 1 BOTTLE (68071-3617-4) 14 tablet2024-06-19NoNoHistorical
68071-3617-66807136170660 TABLET in 1 BOTTLE (68071-3617-6) 60 tablet2024-11-08NoNoHistorical
68071-3617-76807136170721 TABLET in 1 BOTTLE (68071-3617-7) 21 tablet2024-10-16NoNoHistorical
68071-3617-8680713617088 TABLET in 1 BOTTLE (68071-3617-8) 8 tablet2024-06-19NoNoHistorical