FDA.reportPublic FDA data

Prednisone

Product NDC
70954-059
11-digit product format
709540059
Labeler code
70954
Product ID
70954-059_373a92c5-ce0a-4d94-a75c-496751230950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 198146, 198148, 312615, 312617, 763179, 763181, 763183, 763185

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-059-10Prednisone100 in 1 BOTTLETABLET1007
70954-059-20Prednisone1000 in 1 BOTTLETABLET10007
70954-059-30Prednisone1 in 1 BOXTABLET17
70954-059-30Prednisone21 in 1 BLISTER PACKTABLET217
70954-059-40Prednisone1 in 1 BOXTABLET17
70954-059-40Prednisone48 in 1 BLISTER PACKTABLET487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-059-10EA - Each70954-059f819d8f6-71ba-44a9-bc09-92232cedc31d12019-12-10
70954-059-20EA - Each70954-0599abf7b8e-b871-4930-ab98-f0cb669d44ab12019-12-10
70954-059-30EA - Each70954-059d70f50d6-19fb-412b-9321-4c066e9a254f12020-06-05
70954-059-40EA - Each70954-0596b1b1f60-0319-4c60-b704-fc449e97231d12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-059PREDNISONE TABLET [ANI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 6 package rows20250109_f05eb734-07e7-491c-b2e9-aae340e03750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN19fdbf9f-3a64-b9fa-e063-6394a90af08613
198145prednisone 10 MG Oral TabletSCD19fdbf9f-3a64-b9fa-e063-6394a90af08613
198145predniSONE 10 MG Oral TabletPSN71d70ec6-859a-4951-af98-248a864e11359
198145prednisone 10 MG Oral TabletSCD71d70ec6-859a-4951-af98-248a864e11359
763185{21 (prednisone 10 MG Oral Tablet) } PackGPCKf05eb734-07e7-491c-b2e9-aae340e037508
763181{21 (prednisone 5 MG Oral Tablet) } PackGPCKf05eb734-07e7-491c-b2e9-aae340e037508
763183{48 (prednisone 10 MG Oral Tablet) } PackGPCKf05eb734-07e7-491c-b2e9-aae340e037508
763179{48 (prednisone 5 MG Oral Tablet) } PackGPCKf05eb734-07e7-491c-b2e9-aae340e037508
198145predniSONE 10 MG Oral TabletPSN31cfc21f-726b-ae80-e063-6294a90a9af48
198145predniSONE 10 MG Oral TabletPSNf05eb734-07e7-491c-b2e9-aae340e037508
763183predniSONE 10 MG Tablet 12 Day 48 Count PackPSNf05eb734-07e7-491c-b2e9-aae340e037508
763185predniSONE 10 MG Tablet 6 Day 21 Count PackPSNf05eb734-07e7-491c-b2e9-aae340e037508
198146predniSONE 2.5 MG Oral TabletPSNf05eb734-07e7-491c-b2e9-aae340e037508
312615predniSONE 20 MG Oral TabletPSNf05eb734-07e7-491c-b2e9-aae340e037508
312617predniSONE 5 MG Oral TabletPSNf05eb734-07e7-491c-b2e9-aae340e037508
763179predniSONE 5 MG Tablet 12 Day 48 Count PackPSNf05eb734-07e7-491c-b2e9-aae340e037508
763181predniSONE 5 MG Tablet 21 Count PackPSNf05eb734-07e7-491c-b2e9-aae340e037508
198148predniSONE 50 MG Oral TabletPSNf05eb734-07e7-491c-b2e9-aae340e037508
198145prednisone 10 MG Oral TabletSCD31cfc21f-726b-ae80-e063-6294a90a9af48
198145prednisone 10 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
198146prednisone 2.5 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
312615prednisone 20 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
312617prednisone 5 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
198148prednisone 50 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
763185Prednisone 10 MG Oral Tablet 21 Count PackSYf05eb734-07e7-491c-b2e9-aae340e037508
763183Prednisone 10 MG Oral Tablet 48 Count PackSYf05eb734-07e7-491c-b2e9-aae340e037508
763181Prednisone 5 MG Oral Tablet 21 Count PackSYf05eb734-07e7-491c-b2e9-aae340e037508
763179Prednisone 5 MG Oral Tablet 48 Count PackSYf05eb734-07e7-491c-b2e9-aae340e037508
198145predniSONE 10 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198146predniSONE 2.5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312615predniSONE 20 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
312617predniSONE 5 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198148predniSONE 50 MG Oral TabletPSNf499197b-b9b7-1707-e053-2a95a90a09323
198145prednisone 10 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198146prednisone 2.5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312615prednisone 20 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312617prednisone 5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198148prednisone 50 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-059-1070954005910100 TABLET in 1 BOTTLE (70954-059-10) 100 tablet2019-11-150000-00-00NoNoCurrent
70954-059-20709540059201000 TABLET in 1 BOTTLE (70954-059-20) 1000 tablet2019-11-150000-00-00NoNoCurrent
70954-059-30709540059301 BLISTER PACK in 1 BOX (70954-059-30) / 21 TABLET in 1 BLISTER PACK1 blister pack2020-05-280000-00-00NoNoCurrent
70954-059-40709540059401 BLISTER PACK in 1 BOX (70954-059-40) / 48 TABLET in 1 BLISTER PACK1 blister pack2020-05-280000-00-00NoNoCurrent