PREDNISONE

Product NDC
68071-3958
11-digit product format
680713958
Labeler code
68071
Product ID
68071-3958_49535472-f0a8-06ef-e063-6294a90a366f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA215671
Marketing category
ANDA
Marketing start
2021-11-16
Substance
PREDNISONE
Active strength
1 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
PREDNISONE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198144

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
68071-3958-9PREDNISONE90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198144predniSONE 1 MG Oral TabletPSN49535472-f0a7-06ef-e063-6294a90a366f1
198144prednisone 1 MG Oral TabletSCD49535472-f0a7-06ef-e063-6294a90a366f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3958-96807139580990 TABLET in 1 BOTTLE (68071-3958-9) 90 tablet2026-01-26NoNoHistorical