Prednisone

Product NDC
10544-046
11-digit product format
105440046
Labeler code
10544
Product ID
10544-046_112a16d0-4ac7-164d-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA085162
Marketing category
ANDA
Marketing start
2011-06-15
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-046-20Prednisone20 in 1 BOTTLETABLET201
10544-046-30Prednisone30 in 1 BOTTLETABLET301
10544-046-42Prednisone42 in 1 BOTTLETABLET421

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-046-30EA - Each10544-0464a87f1f9-2784-41e7-89ff-a920c667a62b12015-10-02
10544-046-42EA - Each10544-046e8bb245e-251c-45ee-ab8c-9c60de0eff1912015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-046PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 3 package rows20150313_112a16d0-4ac6-164d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
312615predniSONE 20 MG Oral TabletPSN112a16d0-4ac6-164d-e054-00144ff88e881
198145prednisone 10 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881
312615prednisone 20 MG Oral TabletSCD112a16d0-4ac6-164d-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-046-201054400462020 in 1 BOTTLEHistorical
10544-046-301054400463030 in 1 BOTTLEHistorical
10544-046-421054400464242 in 1 BOTTLEHistorical