FDA.reportPublic FDA data

Prednisone

Product NDC
63187-020
11-digit product format
631870020
Labeler code
63187
Product ID
63187-020_df3fb8ca-6e08-4e2b-8e27-db94366273ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Substance
PREDNISONE
Active strength
5 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
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
63187-020-10Prednisone10 in 1 BOTTLETABLET104
63187-020-15Prednisone15 in 1 BOTTLETABLET154
63187-020-21Prednisone21 in 1 BOTTLETABLET214
63187-020-30Prednisone30 in 1 BOTTLETABLET304
63187-020-36Prednisone36 in 1 BOTTLETABLET364

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-020-10EA - Each63187-0208350e774-521d-4e51-9805-1e46ee8a822b12018-11-06
63187-020-15EA - Each63187-0201d11fe76-e299-4851-95fa-2873fe4d624512018-11-06
63187-020-21EA - Each63187-020f10e3e3b-4a39-4baa-bf69-ce45e9d8340012015-07-20
63187-020-36EA - Each63187-020496556de-2136-42cf-8572-5ce8e25f157f12018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PrednisoneACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
PrednisoneACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [PROFICIENT RX LP]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [PROFICIENT RX LP]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [PROFICIENT RX LP]1
Sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JPREDNISONE TABLET [PROFICIENT RX LP]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [PROFICIENT RX LP]1
Starch, PotatoINACTIVE INGREDIENT8I089SAH3TPREDNISONE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-020PREDNISONE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 5 package rows20191025_7c650dc8-43f6-4257-81ed-c93b00202d06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN7c650dc8-43f6-4257-81ed-c93b00202d064
312617prednisone 5 MG Oral TabletSCD7c650dc8-43f6-4257-81ed-c93b00202d064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-020-106318700201010 TABLET in 1 BOTTLE (63187-020-10) 10 tablet2018-09-040000-00-00NoNoCurrent
63187-020-156318700201515 TABLET in 1 BOTTLE (63187-020-15) 15 tablet2018-09-040000-00-00NoNoCurrent
63187-020-216318700202121 TABLET in 1 BOTTLE (63187-020-21) 21 tablet2018-09-040000-00-00NoNoCurrent
63187-020-306318700203030 TABLET in 1 BOTTLE (63187-020-30) 30 tablet2018-09-040000-00-00NoNoCurrent
63187-020-366318700203636 TABLET in 1 BOTTLE (63187-020-36) 36 tablet2018-09-040000-00-00NoNoCurrent