prednisone

Product NDC
51655-349
11-digit product format
516550349
Labeler code
51655
Product ID
51655-349_48eb4c0d-97d6-db3e-e063-6294a90acd7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA208412
Marketing category
ANDA
Marketing start
2022-11-30
Substance
PREDNISONE
Active strength
50 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
PREDNISONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198148

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
51655-349-07prednisone7 in 1 BOTTLE, PLASTICTABLET73
51655-349-55prednisone5 in 1 BOTTLE, PLASTICTABLET53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-349PREDNISONE TABLET [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20240720_f2f1a2ea-fa1b-b4f1-e053-2995a90aa276.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSNf2f1a2ea-fa1b-b4f1-e053-2995a90aa2763
198148prednisone 50 MG Oral TabletSCDf2f1a2ea-fa1b-b4f1-e053-2995a90aa2763

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-349-07516550349077 TABLET in 1 BOTTLE, PLASTIC (51655-349-07) 7 tablet2022-12-30NoNoCurrent
51655-349-55516550349555 TABLET in 1 BOTTLE, PLASTIC (51655-349-55) 5 tablet2022-11-30NoNoCurrent