FDA.reportPublic FDA data

Prednisone

Product NDC
70954-061
11-digit product format
709540061
Labeler code
70954
Product ID
70954-061_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
50 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
PREDNISONE50 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
70954-061-10Prednisone100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-061-10EA - Each70954-061f92bb5c9-4d99-489c-ac02-c2c632da854d12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-061PREDNISONE TABLET [ANI PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20250109_f05eb734-07e7-491c-b2e9-aae340e03750.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSNc60a07f9-ed9f-4434-a69d-2e2fea4843fd103
198148prednisone 50 MG Oral TabletSCDc60a07f9-ed9f-4434-a69d-2e2fea4843fd103
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 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 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
198148predniSONE 50 MG Oral TabletPSN8f7a38c7-7bf9-4951-b529-947cc9a57d6a5
198148prednisone 50 MG Oral TabletSCD8f7a38c7-7bf9-4951-b529-947cc9a57d6a5
198148predniSONE 50 MG Oral TabletPSNfbd3f0c3-06b3-c9b4-e053-6294a90a6fdd4
198148prednisone 50 MG Oral TabletSCDfbd3f0c3-06b3-c9b4-e053-6294a90a6fdd4
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
198148predniSONE 50 MG Oral TabletPSNb9c0665f-444e-d248-e053-2a95a90aa1d42
198148prednisone 50 MG Oral TabletSCDb9c0665f-444e-d248-e053-2a95a90aa1d42
198148predniSONE 50 MG Oral TabletPSN35f504c3-1cf5-455d-8226-9ffeea6066231
198148prednisone 50 MG Oral TabletSCD35f504c3-1cf5-455d-8226-9ffeea6066231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-061-1070954006110100 TABLET in 1 BOTTLE (70954-061-10) 100 tablet2019-11-150000-00-00NoNoCurrent