Prednisone

Product NDC
68387-240
11-digit product format
683870240
Labeler code
68387
Product ID
68387-240_8f56731f-733c-4f54-8fb3-296413c22832
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
2007-04-23
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-240-102019-10-21C16284748780-1956f9ecf-dca4-621f-e053-dbdaa90a74adPREDNISONE TABLETS
68387-240-252019-10-21C16284748780-1956f9ecf-dca4-621f-e053-dbdaa90a74adPREDNISONE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-240-10Prednisone10 in 1 BOTTLE, PLASTICTABLET101
68387-240-25Prednisone25 in 1 BOTTLE, PLASTICTABLET251

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-240-10EA - Each68387-240ec21a07d-84c1-4b9f-8b4d-5062a35c19a012012-07-24
68387-240-25EA - Each68387-240337d6258-5884-4fb8-91ff-bf261263c13712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-240PREDNISONE TABLET [KELTMAN PHARMACEUTICALS INC.]1Legacy NDC, 2 package rows20100706_f4a4cf97-6b6d-4406-a141-7d6a087667aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNf4a4cf97-6b6d-4406-a141-7d6a087667aa1
312615predniSONE 20 MG Oral TabletPSNf4a4cf97-6b6d-4406-a141-7d6a087667aa1
198145prednisone 10 MG Oral TabletSCDf4a4cf97-6b6d-4406-a141-7d6a087667aa1
312615prednisone 20 MG Oral TabletSCDf4a4cf97-6b6d-4406-a141-7d6a087667aa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68387-240-106838702401010 in 1 BOTTLE, PLASTICHistorical
68387-240-256838702402525 in 1 BOTTLE, PLASTICHistorical