FDA.reportPublic FDA data

prednisone

Product NDC
50090-7218
11-digit product format
500907218
Labeler code
50090
Product ID
50090-7218_854dd790-2b3d-4b8a-bd1d-2ea112c6a01c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
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
50090-7218-0prednisone10 in 1 BOTTLETABLET104
50090-7218-1prednisone15 in 1 BOTTLETABLET154
50090-7218-2prednisone21 in 1 BOTTLETABLET214
50090-7218-4prednisone50 in 1 BOTTLETABLET504
50090-7218-5prednisone30 in 1 BOTTLETABLET304
50090-7218-7prednisone100 in 1 BOTTLETABLET1004
50090-7218-8prednisone40 in 1 BOTTLETABLET404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7218-0EA - Each50090-7218d21d8a34-ea56-49df-8853-9a27486de3a112024-09-09
50090-7218-1EA - Each50090-721818c44860-9137-4a4c-a503-dc9c9565fa2312024-09-09
50090-7218-2EA - Each50090-72187b0f0e4f-0fb6-47f4-80b7-e831d9759d6312024-09-09
50090-7218-4EA - Each50090-72180e2f0f72-e4ae-4115-9c2c-c533bf72f57012024-09-09
50090-7218-5EA - Each50090-721895b3eb57-0724-4848-a688-7e245fa6e5d412024-09-09
50090-7218-7EA - Each50090-7218bcb77984-f393-48f2-9b4c-0a5b746a317f12024-09-09
50090-7218-8EA - Each50090-72183bd95125-7037-4083-b85a-4724ca7c7e0a12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7218PREDNISONE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 7 package rows20240816_f4cc64f8-781f-437a-a4a7-2d163026d1c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf4cc64f8-781f-437a-a4a7-2d163026d1c24
198145prednisone 10 MG Oral TabletSCDf4cc64f8-781f-437a-a4a7-2d163026d1c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7218-05009072180010 TABLET in 1 BOTTLE (50090-7218-0) 10 tablet2024-08-13NoNoHistorical
50090-7218-15009072180115 TABLET in 1 BOTTLE (50090-7218-1) 15 tablet2024-08-13NoNoHistorical
50090-7218-25009072180221 TABLET in 1 BOTTLE (50090-7218-2) 21 tablet2024-08-13NoNoHistorical
50090-7218-45009072180450 TABLET in 1 BOTTLE (50090-7218-4) 50 tablet2024-08-13NoNoHistorical
50090-7218-55009072180530 TABLET in 1 BOTTLE (50090-7218-5) 30 tablet2024-08-13NoNoHistorical
50090-7218-750090721807100 TABLET in 1 BOTTLE (50090-7218-7) 100 tablet2024-08-13NoNoHistorical
50090-7218-85009072180840 TABLET in 1 BOTTLE (50090-7218-8) 40 tablet2024-08-13NoNoHistorical