FDA.reportPublic FDA data

Prednisone

Product NDC
72189-589
11-digit product format
721890589
Labeler code
72189
Product ID
72189-589_410c34bc-cd00-f063-e063-6394a90aa7f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA208412
Marketing category
ANDA
Marketing start
2024-10-15
Substance
PREDNISONE
Active strength
10 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
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
72189-589-10Prednisone10 in 1 BOTTLETABLET104
72189-589-15Prednisone15 in 1 BOTTLETABLET154
72189-589-21Prednisone21 in 1 BOTTLETABLET214
72189-589-30Prednisone30 in 1 BOTTLETABLET304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-589-10EA - Each72189-589330c308c-fd47-4c0d-8df4-520a7938fe3812025-09-12
72189-589-15EA - Each72189-589bd41b7cc-f247-4794-b34f-563e40ac6d5112025-11-13
72189-589-21EA - Each72189-589f46fc29a-5cce-469f-93aa-6b164d02ba1312024-12-10
72189-589-30EA - Each72189-589632af463-40be-40f9-8916-f20d155e445712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-589PREDNISONE TABLET [DIRECT_RX]2Current NDC, 4 package rows20241103_24882e23-c05f-f2ee-e063-6294a90a536f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN24882e23-c05f-f2ee-e063-6294a90a536f4
198145prednisone 10 MG Oral TabletSCD24882e23-c05f-f2ee-e063-6294a90a536f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-589-107218905891010 TABLET in 1 BOTTLE (72189-589-10) 10 tablet2024-10-15NoNoHistorical
72189-589-157218905891515 TABLET in 1 BOTTLE (72189-589-15) 15 tablet2024-10-15NoNoHistorical
72189-589-217218905892121 TABLET in 1 BOTTLE (72189-589-21) 21 tablet2024-10-15NoNoHistorical
72189-589-307218905893030 TABLET in 1 BOTTLE (72189-589-30) 30 tablet2024-10-15NoNoHistorical