FDA.reportPublic FDA data

Prednisone

Product NDC
70954-060
11-digit product format
709540060
Labeler code
70954
Product ID
70954-060_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
20 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
PREDNISONE20 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
70954-060-10Prednisone100 in 1 BOTTLETABLET1007
70954-060-20Prednisone500 in 1 BOTTLETABLET5007
70954-060-30Prednisone1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-060-10EA - Each70954-06080ac319e-b990-48ef-999e-d4d98b6f84a612019-12-10
70954-060-20EA - Each70954-060828d3630-cca2-4e7e-80f7-cfb5524e818112019-12-10
70954-060-30EA - Each70954-0607ab0a313-f542-468d-992d-5382d40076d712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-060PREDNISONE TABLET [ANI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20250109_f05eb734-07e7-491c-b2e9-aae340e03750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN1349a022-639b-4494-99a2-1594c7c0f0e917
312615prednisone 20 MG Oral TabletSCD1349a022-639b-4494-99a2-1594c7c0f0e917
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 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 TabletPSN25b5958b-c151-9200-e063-6394a90af52c8
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 TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
198146prednisone 2.5 MG Oral TabletSCDf05eb734-07e7-491c-b2e9-aae340e037508
312615prednisone 20 MG Oral TabletSCD25b5958b-c151-9200-e063-6394a90af52c8
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
312615predniSONE 20 MG Oral TabletPSN1b42449a-2be8-e4fb-e063-6394a90aff985
312615prednisone 20 MG Oral TabletSCD1b42449a-2be8-e4fb-e063-6394a90aff985
312615predniSONE 20 MG Oral TabletPSN67681e4e-3002-4428-af5e-6ff1a950b0374
312615prednisone 20 MG Oral TabletSCD67681e4e-3002-4428-af5e-6ff1a950b0374
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
312615predniSONE 20 MG Oral TabletPSN1b3ea4cc-5bc6-ae47-e063-6294a90af13d3
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
312615prednisone 20 MG Oral TabletSCD1b3ea4cc-5bc6-ae47-e063-6294a90af13d3
312617prednisone 5 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
198148prednisone 50 MG Oral TabletSCDf499197b-b9b7-1707-e053-2a95a90a09323
312615predniSONE 20 MG Oral TabletPSNf40eb4e3-661a-bb82-e053-2995a90a9b0c2
312615predniSONE 20 MG Oral TabletPSN30956dd5-fe19-d5a9-e063-6394a90a25492
312615prednisone 20 MG Oral TabletSCDf40eb4e3-661a-bb82-e053-2995a90a9b0c2
312615prednisone 20 MG Oral TabletSCD30956dd5-fe19-d5a9-e063-6394a90a25492
312615predniSONE 20 MG Oral TabletPSN1c33879e-8b2b-5843-e063-6294a90adea41
312615prednisone 20 MG Oral TabletSCD1c33879e-8b2b-5843-e063-6294a90adea41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-060-1070954006010100 TABLET in 1 BOTTLE (70954-060-10) 100 tablet2019-11-150000-00-00NoNoCurrent
70954-060-2070954006020500 TABLET in 1 BOTTLE (70954-060-20) 500 tablet2019-11-150000-00-00NoNoCurrent
70954-060-30709540060301000 TABLET in 1 BOTTLE (70954-060-30) 1000 tablet2019-11-150000-00-00NoNoCurrent