PredniSONE

Product NDC
55154-4946
11-digit product format
551544946
Labeler code
55154
Product ID
55154-4946_cd5fb2e0-dec1-4ccf-b34b-4d35c9752965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA087342
Marketing category
ANDA
Marketing start
2003-02-13
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-4946-0EA - Each55154-494612c4680a-d6a0-4915-ab04-cf0b38e98a3312020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [CARDINAL HEALTH]8
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [CARDINAL HEALTH]8
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPREDNISONE TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [CARDINAL HEALTH]8
SODIUM GLYCOLATEINACTIVE INGREDIENTB75E535IMIPREDNISONE TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [CARDINAL HEALTH]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [CARDINAL HEALTH]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4946PREDNISONE TABLET [CARDINAL HEALTH 107, LLC]26Legacy NDC20241030_9a76c658-6658-47a7-8f8d-b3994aef8585.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4946-05515449460010 BLISTER PACK in 1 BAG (55154-4946-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2003-02-130000-00-00NoNoCurrent