FDA.reportPublic FDA data

Prednisone

Product NDC
0143-9738
11-digit product format
001439738
Labeler code
0143
Product ID
0143-9738_92e5952b-2b1e-42c7-a8b3-c33d403d47aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceuticals Corp
Application
ANDA083677
Marketing category
ANDA
Marketing start
2009-08-03
Marketing end
2022-08-31
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9738-01EA - Each0143-973807fe7327-3f2a-4696-8331-6383d300ce8a12013-08-02
0143-9738-05EA - Each0143-9738432027db-c808-449a-90db-1aa4bc155e4712013-08-02
0143-9738-10EA - Each0143-9738a694402e-ec69-4b4b-850e-76bafd5ed67c12013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [LIBERTY PHARMACEUTICALS, INC.]3
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECT RX]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECTRX]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECT RX]2
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECTRX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [DIRECTRX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [DIRECT RX]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [DIRECTRX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREDNISONE TABLET [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [DIRECTRX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [DIRECT RX]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DIRECTRX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECTRX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [DIRECTRX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UPREDNISONE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN615fc25c-4a28-448f-ac8c-1fd269e65d613
312615prednisone 20 MG Oral TabletSCD615fc25c-4a28-448f-ac8c-1fd269e65d613
198145predniSONE 10 MG Oral TabletPSN0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615predniSONE 20 MG Oral TabletPSN0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615predniSONE 20 MG Oral TabletPSN60aa55bf-169b-4cf3-b5d9-c3bebef6c4ae2
312615predniSONE 20 MG Oral TabletPSN7f6cdd3c-7732-49e6-93b2-359c67c4ed602
312615predniSONE 20 MG Oral TabletPSN9547efb2-4f56-4556-b15c-daff3683ce132
198145prednisone 10 MG Oral TabletSCD0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615prednisone 20 MG Oral TabletSCD0fc4b18c-3025-12f2-e054-00144ff8d46c2
312615prednisone 20 MG Oral TabletSCD60aa55bf-169b-4cf3-b5d9-c3bebef6c4ae2
312615prednisone 20 MG Oral TabletSCD7f6cdd3c-7732-49e6-93b2-359c67c4ed602
312615prednisone 20 MG Oral TabletSCD9547efb2-4f56-4556-b15c-daff3683ce132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9738-0500143973805500 TABLET in 1 BOTTLE (0143-9738-05) 500 tablet2009-08-032022-08-31NoNoCurrent