Prednisone

Product NDC
45865-638
11-digit product format
458650638
Labeler code
45865
Product ID
45865-638_9ab3574a-86b3-51b6-e053-2a95a90a52d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA040256
Marketing category
ANDA
Marketing start
2002-07-12
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-638-212023-01-30C16284748780-1f386c649-d0e3-0266-e053-dadaa90a7c1aPredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-638-21Prednisone21 in 1 BOX, UNIT-DOSETABLET212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-638PREDNISONE TABLET [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20191228_1f7fd914-09b3-664e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSN1f7fd914-09b3-664e-e054-00144ff88e882
312617prednisone 5 MG Oral TabletSCD1f7fd914-09b3-664e-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-638-214586506382121 TABLET in 1 BOX, UNIT-DOSE (45865-638-21) 21 tablet2015-09-110000-00-00NoNoCurrent