FDA.reportPublic FDA data

Prednisone

Product NDC
10544-274
11-digit product format
105440274
Labeler code
10544
Product ID
10544-274_0effd72e-4693-2bfa-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040584
Marketing category
ANDA
Marketing start
2013-11-15
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
1 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
10544-274-212020-01-31C16284748780-19d75b9d0-021a-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 5 mg
10544-274-302020-01-31C16284748780-19d75b9d0-021a-f424-e053-dadaa90a57cePredniSONE TABLETS, USP 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-274-21Prednisone21 in 1 BOTTLE, PLASTICTABLET212
10544-274-30Prednisone30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-274-21EA - Each10544-274045c8bc1-0ca6-4d31-af24-5718ca0ea7bb12015-10-02
10544-274-30EA - Each10544-274faf88335-97d0-4735-a453-747530d96f7512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-274PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 2 package rows20150214_0efebe35-3e8d-3895-e054-00144ff88e88.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-274-211054402742121 in 1 BOTTLE, PLASTICHistorical
10544-274-301054402743030 in 1 BOTTLE, PLASTICHistorical