FDA.reportPublic FDA data

prednisone

Product NDC
50090-7369
11-digit product format
500907369
Labeler code
50090
Product ID
50090-7369_fb19319b-dc08-4c85-827a-0a388877b29c
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
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
50090-7369-0prednisone10 in 1 BOTTLETABLET104
50090-7369-1prednisone15 in 1 BOTTLETABLET154
50090-7369-2prednisone21 in 1 BOTTLETABLET214
50090-7369-4prednisone50 in 1 BOTTLETABLET504
50090-7369-5prednisone30 in 1 BOTTLETABLET304
50090-7369-7prednisone100 in 1 BOTTLETABLET1004
50090-7369-8prednisone40 in 1 BOTTLETABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7369-0EA - Each50090-7369d8ff766a-6ff7-4540-9374-10fddab64eda12024-12-10
50090-7369-1EA - Each50090-73690d6f3c48-e1b1-427d-bd73-9be28c07bfb712024-12-10
50090-7369-2EA - Each50090-73690cf594c7-0c9b-4267-ae6d-28dc9cd25b1312024-12-10
50090-7369-4EA - Each50090-7369160ba93a-e248-461a-a63e-ccd1a8d5c80012024-12-10
50090-7369-5EA - Each50090-7369583020a0-c948-4730-b621-53b6111b435a12024-12-10
50090-7369-7EA - Each50090-73699260c708-2acd-4134-b442-9a4ea444ca4912024-12-10
50090-7369-8EA - Each50090-7369ce5632e5-9bfd-40ae-b64b-901ddeea1af812024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7369PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 7 package rows20241024_aaea2307-7893-48e9-af64-26172d08d4e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNaaea2307-7893-48e9-af64-26172d08d4e84
198145prednisone 10 MG Oral TabletSCDaaea2307-7893-48e9-af64-26172d08d4e84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7369-05009073690010 TABLET in 1 BOTTLE (50090-7369-0) 10 tablet2024-10-18NoNoCurrent
50090-7369-15009073690115 TABLET in 1 BOTTLE (50090-7369-1) 15 tablet2024-10-18NoNoCurrent
50090-7369-25009073690221 TABLET in 1 BOTTLE (50090-7369-2) 21 tablet2024-10-18NoNoCurrent
50090-7369-45009073690450 TABLET in 1 BOTTLE (50090-7369-4) 50 tablet2024-10-18NoNoCurrent
50090-7369-55009073690530 TABLET in 1 BOTTLE (50090-7369-5) 30 tablet2024-10-18NoNoCurrent
50090-7369-750090736907100 TABLET in 1 BOTTLE (50090-7369-7) 100 tablet2024-10-18NoNoCurrent
50090-7369-85009073690840 TABLET in 1 BOTTLE (50090-7369-8) 40 tablet2024-10-18NoNoCurrent