Prednisone

Product NDC
10544-509
11-digit product format
105440509
Labeler code
10544
Product ID
10544-509_e14b112a-d01a-4d96-ae6a-7c6466245809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
2010-03-17
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
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-509-07Prednisone7 in 1 BOTTLETABLET71
10544-509-10Prednisone10 in 1 BOTTLETABLET101
10544-509-12Prednisone12 in 1 BOTTLETABLET121
10544-509-15Prednisone15 in 1 BOTTLETABLET151
10544-509-20Prednisone20 in 1 BOTTLETABLET201
10544-509-30Prednisone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-509-07EA - Each10544-50995f577cf-db5d-4f33-b467-3fbc3caf935d12015-10-02
10544-509-10EA - Each10544-50929ecb4aa-45f1-4d69-a22d-1475aee472f212015-10-02
10544-509-12EA - Each10544-5091b35cbf8-70d9-473b-aca6-5a111d12d94e12015-10-02
10544-509-15EA - Each10544-50998f4d965-a99c-4b45-8777-2ff4267a821d12015-10-02
10544-509-20EA - Each10544-5095ff776ee-533a-4eee-8358-8ea0503f20bc12015-10-02

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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-509PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 6 package rows20130524_f25a6e4d-7966-4ebd-94e9-7fe9cadb897b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf25a6e4d-7966-4ebd-94e9-7fe9cadb897b1
312615predniSONE 20 MG Oral TabletPSNf25a6e4d-7966-4ebd-94e9-7fe9cadb897b1
198145prednisone 10 MG Oral TabletSCDf25a6e4d-7966-4ebd-94e9-7fe9cadb897b1
312615prednisone 20 MG Oral TabletSCDf25a6e4d-7966-4ebd-94e9-7fe9cadb897b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-509-07105440509077 in 1 BOTTLEHistorical
10544-509-101054405091010 in 1 BOTTLEHistorical
10544-509-121054405091212 in 1 BOTTLEHistorical
10544-509-151054405091515 in 1 BOTTLEHistorical
10544-509-201054405092020 in 1 BOTTLEHistorical
10544-509-301054405093030 in 1 BOTTLEHistorical