FDA.reportPublic FDA data

PredniSONE

Product NDC
51655-701
11-digit product format
516550701
Labeler code
51655
Product ID
51655-701_4950ead0-97a4-b291-e063-6294a90a6026
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA087342
Marketing category
ANDA
Marketing start
2021-04-19
Substance
PREDNISONE
Active strength
20 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-701-182023-03-27C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-701-202023-03-27C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-701-532023-03-27C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-701-182023-01-30C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-701-202023-01-30C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP
51655-701-532023-01-30C16284748780-1f386c649-c20c-0266-e053-dadaa90a7c1aPredniSONE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-701-18PredniSONE18 in 1 BOTTLE, PLASTICTABLET184
51655-701-20PredniSONE20 in 1 BOTTLE, PLASTICTABLET204
51655-701-53PredniSONE10 in 1 BOTTLE, PLASTICTABLET104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-701PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 3 package rows20241228_ca39fdfb-d110-6535-e053-2995a90a550a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNca39fdfb-d110-6535-e053-2995a90a550a4
312615prednisone 20 MG Oral TabletSCDca39fdfb-d110-6535-e053-2995a90a550a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51655-701-185165507011818 TABLET in 1 BOTTLE, PLASTIC (51655-701-18) 18 tablet2021-06-100000-00-00NoNoCurrent
51655-701-205165507012020 TABLET in 1 BOTTLE, PLASTIC (51655-701-20) 20 tablet2021-06-100000-00-00NoNoCurrent
51655-701-535165507015310 TABLET in 1 BOTTLE, PLASTIC (51655-701-53) 10 tablet2021-04-190000-00-00NoNoCurrent