FDA.reportPublic FDA data

Prednisone

Product NDC
72189-430
11-digit product format
721890430
Labeler code
72189
Product ID
72189-430_5114bc54-15c7-dc8a-e063-6294a90aa011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA208412
Marketing category
ANDA
Marketing start
2023-03-03
Substance
PREDNISONE
Active strength
20 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
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
72189-430-05Prednisone5 in 1 BOTTLETABLET56
72189-430-06Prednisone6 in 1 BOTTLETABLET66
72189-430-10Prednisone10 in 1 BOTTLETABLET106
72189-430-15Prednisone15 in 1 BOTTLETABLET156
72189-430-20Prednisone20 in 1 BOTTLETABLET206
72189-430-21Prednisone21 in 1 BOTTLETABLET216
72189-430-30Prednisone30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-430-05EA - Each72189-4301e009d9e-201a-4cba-81db-055f3fb1d55012023-10-16
72189-430-10EA - Each72189-4303fb643eb-d433-4263-9548-c3b6369cbc9612023-04-07
72189-430-15EA - Each72189-4307c45f877-e5b3-412b-942f-35871154a7fb12024-06-10
72189-430-20EA - Each72189-43027a74ba2-e73d-46d1-b3d2-7217632329eb12023-04-07
72189-430-21EA - Each72189-430fb2b1f12-7425-41fa-b03e-646a34451add12023-04-07
72189-430-30EA - Each72189-43088e288c3-c214-4ab7-b069-6f2979c3986912026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-430PREDNISONE TABLET [DIRECT_RX]4Current NDC, 7 package rows20240509_f6051257-2144-4487-e053-2995a90a973b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNf6051257-2144-4487-e053-2995a90a973b6
312615prednisone 20 MG Oral TabletSCDf6051257-2144-4487-e053-2995a90a973b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-430-05721890430055 TABLET in 1 BOTTLE (72189-430-05) 5 tablet2023-03-03NoNoHistorical
72189-430-06721890430066 TABLET in 1 BOTTLE (72189-430-06) 6 tablet2023-03-03NoNoHistorical
72189-430-107218904301010 TABLET in 1 BOTTLE (72189-430-10) 10 tablet2023-03-03NoNoHistorical
72189-430-157218904301515 TABLET in 1 BOTTLE (72189-430-15) 15 tablet2023-03-03NoNoHistorical
72189-430-207218904302020 TABLET in 1 BOTTLE (72189-430-20) 20 tablet2023-03-03NoNoHistorical
72189-430-217218904302121 TABLET in 1 BOTTLE (72189-430-21) 21 tablet2023-03-03NoNoHistorical
72189-430-307218904303030 TABLET in 1 BOTTLE (72189-430-30) 30 tablet2023-03-03NoNoHistorical