FDA.reportPublic FDA data

prednisone

Product NDC
50090-6123
11-digit product format
500906123
Labeler code
50090
Product ID
50090-6123_77958ed5-1eaa-43ab-afcf-a380652a664f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA213386
Marketing category
ANDA
Marketing start
2020-06-24
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
50090-6123-0prednisone20 in 1 BOTTLETABLET209
50090-6123-1prednisone12 in 1 BOTTLETABLET129
50090-6123-2prednisone6 in 1 BOTTLETABLET69
50090-6123-5prednisone14 in 1 BOTTLETABLET149
50090-6123-7prednisone15 in 1 BOTTLETABLET159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6123-0EA - Each50090-61233f95ac14-6445-41f4-b407-3b26cd7ce93d12022-11-07
50090-6123-1EA - Each50090-61238b9e2ce8-5ef2-4bbd-8bf7-0e99bbfdbda212022-11-07
50090-6123-2EA - Each50090-6123e34c2831-e753-442e-879a-a1ae5840aed612022-11-07
50090-6123-5EA - Each50090-6123c3246124-f5b3-4331-98f9-431c85cb2edc12022-11-07
50090-6123-7EA - Each50090-612389c0d7d7-14b1-4c4c-a30d-c715ae6a99d812022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6123PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 5 package rows20240605_e28359cf-0c21-487a-a1a3-d1c62cef88f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNe28359cf-0c21-487a-a1a3-d1c62cef88f99
312615prednisone 20 MG Oral TabletSCDe28359cf-0c21-487a-a1a3-d1c62cef88f99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6123-05009061230020 TABLET in 1 BOTTLE (50090-6123-0) 20 tablet2022-09-300000-00-00NoNoCurrent
50090-6123-15009061230112 TABLET in 1 BOTTLE (50090-6123-1) 12 tablet2022-09-300000-00-00NoNoCurrent
50090-6123-2500906123026 TABLET in 1 BOTTLE (50090-6123-2) 6 tablet2022-09-300000-00-00NoNoCurrent
50090-6123-55009061230514 TABLET in 1 BOTTLE (50090-6123-5) 14 tablet2022-09-300000-00-00NoNoCurrent
50090-6123-75009061230715 TABLET in 1 BOTTLE (50090-6123-7) 15 tablet2022-09-300000-00-00NoNoCurrent