FDA.reportPublic FDA data

Prednisone

Product NDC
51655-410
11-digit product format
516550410
Labeler code
51655
Product ID
51655-410_48ff0341-60c9-05c3-e063-6294a90a031b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA085162
Marketing category
ANDA
Marketing start
2014-04-28
Substance
PREDNISONE
Active strength
10 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
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-410-202023-03-21C16284748780-19d75b9cf-efff-f424-e053-dadaa90a57cepredniSONE Tablets, USP Rx only
51655-410-492023-03-21C16284748780-19d75b9cf-efff-f424-e053-dadaa90a57cepredniSONE Tablets, USP Rx only
51655-410-202020-01-31C16284748780-19d75b9cf-efff-f424-e053-dadaa90a57cepredniSONE Tablets, USP Rx only
51655-410-492020-01-31C16284748780-19d75b9cf-efff-f424-e053-dadaa90a57cepredniSONE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-410-20Prednisone20 in 1 BOTTLETABLET206
51655-410-21Prednisone21 in 1 BOTTLE, PLASTICTABLET216
51655-410-27Prednisone12 in 1 BOTTLE, PLASTICTABLET126
51655-410-49Prednisone42 in 1 BOTTLETABLET426
51655-410-52Prednisone30 in 1 BOTTLE, PLASTICTABLET306
51655-410-53Prednisone10 in 1 BOTTLE, PLASTICTABLET106
51655-410-54Prednisone15 in 1 BOTTLE, PLASTICTABLET156

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [NORTHWIND PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-410PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 7 package rows20241220_0f377d9f-b2f4-4dae-b503-5f963bea281f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN0f377d9f-b2f4-4dae-b503-5f963bea281f6
198145prednisone 10 MG Oral TabletSCD0f377d9f-b2f4-4dae-b503-5f963bea281f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-410-205165504102020 TABLET in 1 BOTTLE (51655-410-20) 20 tablet2014-04-28NoNoCurrent
51655-410-215165504102121 TABLET in 1 BOTTLE, PLASTIC (51655-410-21) 21 tablet2021-06-10NoNoCurrent
51655-410-275165504102712 TABLET in 1 BOTTLE, PLASTIC (51655-410-27) 12 tablet2023-03-03NoNoCurrent
51655-410-495165504104942 TABLET in 1 BOTTLE (51655-410-49) 42 tablet2014-04-28NoNoCurrent
51655-410-525165504105230 TABLET in 1 BOTTLE, PLASTIC (51655-410-52) 30 tablet2020-04-10NoNoCurrent
51655-410-535165504105310 TABLET in 1 BOTTLE, PLASTIC (51655-410-53) 10 tablet2023-03-15NoNoCurrent
51655-410-545165504105415 TABLET in 1 BOTTLE, PLASTIC (51655-410-54) 15 tablet2021-05-12NoNoCurrent