FDA.reportPublic FDA data

prednisone

Product NDC
64380-784
11-digit product format
643800784
Labeler code
64380
Product ID
64380-784_bdf0b63b-7d6e-4799-be31-cdbf94e02145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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, 198148, 312615

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
64380-784-01prednisone10 in 1 CARTONTABLET1011
64380-784-01prednisone10 in 1 BLISTER PACKTABLET1011
64380-784-06prednisone100 in 1 BOTTLE, PLASTICTABLET10011
64380-784-07prednisone500 in 1 BOTTLE, PLASTICTABLET50011
64380-784-08prednisone1000 in 1 BOTTLE, PLASTICTABLET100011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-784PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 5 package rows20240316_2ef05381-faad-4e0f-b58d-9f2236a04a2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNecc48869-3812-4440-a398-749b28062059105
198145prednisone 10 MG Oral TabletSCDecc48869-3812-4440-a398-749b28062059105
198145predniSONE 10 MG Oral TabletPSNa2ba1a31-9e2d-4c1e-9bbd-b813831ce08f104
198145prednisone 10 MG Oral TabletSCDa2ba1a31-9e2d-4c1e-9bbd-b813831ce08f104
198145predniSONE 10 MG Oral TabletPSN5218e88b-468b-4d60-ab7e-78cca632b23a18
198145prednisone 10 MG Oral TabletSCD5218e88b-468b-4d60-ab7e-78cca632b23a18
198145predniSONE 10 MG Oral TabletPSNb3b70d6f-dc44-4a54-b39b-2762f37d557511
198145predniSONE 10 MG Oral TabletPSN2ef05381-faad-4e0f-b58d-9f2236a04a2c11
312615predniSONE 20 MG Oral TabletPSN2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198148predniSONE 50 MG Oral TabletPSN2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198145prednisone 10 MG Oral TabletSCDb3b70d6f-dc44-4a54-b39b-2762f37d557511
198145prednisone 10 MG Oral TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
312615prednisone 20 MG Oral TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198148prednisone 50 MG Oral TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198145predniSONE 10 MG Oral TabletPSNc2f477da-0b99-4fc4-89ca-94831de950a35
198145prednisone 10 MG Oral TabletSCDc2f477da-0b99-4fc4-89ca-94831de950a35
198145predniSONE 10 MG Oral TabletPSNce7663a7-4c91-4790-aa43-96f259b3bb184
198145predniSONE 10 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
198145predniSONE 10 MG Oral TabletPSN24882e23-c05f-f2ee-e063-6294a90a536f4
198145predniSONE 10 MG Oral TabletPSNf795ea1d-f41a-6100-e053-6394a90a63a44
198145predniSONE 10 MG Oral TabletPSN90b8b43e-01f9-4503-91c4-2b3cbae91a834
198145predniSONE 10 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145predniSONE 10 MG Oral TabletPSNf4cc64f8-781f-437a-a4a7-2d163026d1c24
312615predniSONE 20 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615predniSONE 20 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
198148predniSONE 50 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148predniSONE 50 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
198145prednisone 10 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145prednisone 10 MG Oral TabletSCDce7663a7-4c91-4790-aa43-96f259b3bb184
198145prednisone 10 MG Oral TabletSCD90b8b43e-01f9-4503-91c4-2b3cbae91a834
198145prednisone 10 MG Oral TabletSCDf795ea1d-f41a-6100-e053-6394a90a63a44
198145prednisone 10 MG Oral TabletSCDf4cc64f8-781f-437a-a4a7-2d163026d1c24
198145prednisone 10 MG Oral TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
198145prednisone 10 MG Oral TabletSCD24882e23-c05f-f2ee-e063-6294a90a536f4
312615prednisone 20 MG Oral TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
312615prednisone 20 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148prednisone 50 MG Oral TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
198148prednisone 50 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145predniSONE 10 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
198145predniSONE 10 MG Oral TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615predniSONE 20 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
312615predniSONE 20 MG Oral TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312617predniSONE 5 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
198145prednisone 10 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
198145prednisone 10 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615prednisone 20 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
312615prednisone 20 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312617prednisone 5 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
198145predniSONE 10 MG Oral TabletPSNdb4a13ff-546d-15b7-e053-2a95a90a6adf2
198145prednisone 10 MG Oral TabletSCDdb4a13ff-546d-15b7-e053-2a95a90a6adf2
198145predniSONE 10 MG Oral TabletPSNdf371872-2983-7951-e053-2a95a90ad7571
198145predniSONE 10 MG Oral TabletPSNea4070e1-080d-4feb-9561-3910c6b712dd1
198145predniSONE 10 MG Oral TabletPSN3e0e3e28-e6ff-7b48-e063-6294a90a9acd1
198145prednisone 10 MG Oral TabletSCDdf371872-2983-7951-e053-2a95a90ad7571
198145prednisone 10 MG Oral TabletSCDea4070e1-080d-4feb-9561-3910c6b712dd1
198145prednisone 10 MG Oral TabletSCD3e0e3e28-e6ff-7b48-e063-6294a90a9acd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-784-016438007840110 BLISTER PACK in 1 CARTON (64380-784-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2021-09-010000-00-00NoNoCurrent
64380-784-0664380078406100 TABLET in 1 BOTTLE, PLASTIC (64380-784-06) 100 tablet2021-09-010000-00-00NoNoCurrent
64380-784-0764380078407500 TABLET in 1 BOTTLE, PLASTIC (64380-784-07) 500 tablet2021-09-010000-00-00NoNoCurrent
64380-784-08643800784081000 TABLET in 1 BOTTLE, PLASTIC (64380-784-08) 1000 tablet2021-09-010000-00-00NoNoCurrent