FDA.reportPublic FDA data

PREDNISONE

Product NDC
68071-3746
11-digit product format
680713746
Labeler code
68071
Product ID
68071-3746_4a032fba-f907-4a13-e063-6294a90a2508
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA215672
Marketing category
ANDA
Marketing start
2022-03-28
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PREDNISONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145

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
68071-3746-0PREDNISONE10 in 1 BOTTLETABLET106
68071-3746-1PREDNISONE21 in 1 BOTTLETABLET216
68071-3746-2PREDNISONE20 in 1 BOTTLETABLET206
68071-3746-3PREDNISONE30 in 1 BOTTLETABLET306
68071-3746-5PREDNISONE15 in 1 BOTTLETABLET156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3746PREDNISONE TABLET [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 5 package rows20241226_292e2529-711c-7b74-e063-6394a90a660d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN292e2529-711c-7b74-e063-6394a90a660d6
198145prednisone 10 MG Oral TabletSCD292e2529-711c-7b74-e063-6394a90a660d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3746-06807137460010 TABLET in 1 BOTTLE (68071-3746-0) 10 tablet2024-12-13NoNoHistorical
68071-3746-16807137460121 TABLET in 1 BOTTLE (68071-3746-1) 21 tablet2025-11-11NoNoHistorical
68071-3746-26807137460220 TABLET in 1 BOTTLE (68071-3746-2) 20 tablet2024-12-13NoNoHistorical
68071-3746-36807137460330 TABLET in 1 BOTTLE (68071-3746-3) 30 tablet2026-02-04NoNoHistorical
68071-3746-56807137460515 TABLET in 1 BOTTLE (68071-3746-5) 15 tablet2024-12-13NoNoHistorical