FDA.reportPublic FDA data

Prednisone

Product NDC
10544-473
11-digit product format
105440473
Labeler code
10544
Product ID
10544-473_1b8eb062-6cc0-17fe-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
2014-02-25
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
10544-473-202020-01-31C16284748780-19d75b9d0-72c7-f424-e053-dadaa90a57cePREDNISONE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-473-20Prednisone20 in 1 BOTTLETABLET202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-473-20EA - Each10544-47305cdf4ee-f539-4df8-a63b-3f65816ec0b412015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-473PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20150723_0fc4b18c-3025-12f2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615predniSONE 20 MG Oral TabletPSN0fc4b18c-3025-12f2-e054-00144ff8d46c2
198145prednisone 10 MG Oral TabletSCD0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615prednisone 20 MG Oral TabletSCD0fc4b18c-3025-12f2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-473-201054404732020 in 1 BOTTLEHistorical