prednisone

Product NDC
64380-949
11-digit product format
643800949
Labeler code
64380
Product ID
64380-949_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
2022-05-24
Substance
PREDNISONE
Active strength
50 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
PREDNISONE50 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
64380-949-01prednisone10 in 1 CARTONTABLET1011
64380-949-01prednisone10 in 1 BLISTER PACKTABLET1011
64380-949-06prednisone100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-949-06EA - Each64380-949a722fdcd-0431-40be-b467-ca50da36606712022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-949PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 3 package rows20240316_2ef05381-faad-4e0f-b58d-9f2236a04a2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198148predniSONE 50 MG Oral TabletPSN70d05ed7-5c4e-4cd1-84cd-0dbe90692c54103
198148prednisone 50 MG Oral TabletSCD70d05ed7-5c4e-4cd1-84cd-0dbe90692c54103
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 TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
312615prednisone 20 MG Oral TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198148prednisone 50 MG Oral TabletSCD2ef05381-faad-4e0f-b58d-9f2236a04a2c11
198148predniSONE 50 MG Oral TabletPSNb540f4af-8f07-4c56-b151-d759440c514a6
198148prednisone 50 MG Oral TabletSCDb540f4af-8f07-4c56-b151-d759440c514a6
198145predniSONE 10 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
198145predniSONE 10 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615predniSONE 20 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
312615predniSONE 20 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
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 TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
312615prednisone 20 MG Oral TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
312615prednisone 20 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148prednisone 50 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148prednisone 50 MG Oral TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
198148predniSONE 50 MG Oral TabletPSNc7c3bb80-73b6-4128-aa5f-0d465a1d84e83
198148predniSONE 50 MG Oral TabletPSNf2f1a2ea-fa1b-b4f1-e053-2995a90aa2763
198148prednisone 50 MG Oral TabletSCDc7c3bb80-73b6-4128-aa5f-0d465a1d84e83
198148prednisone 50 MG Oral TabletSCDf2f1a2ea-fa1b-b4f1-e053-2995a90aa2763
198148predniSONE 50 MG Oral TabletPSN5dde7256-d3b8-400d-a0eb-c60078bfc5d92
198148predniSONE 50 MG Oral TabletPSNfd8eb82e-52df-c368-e053-6294a90ac6b02
198148predniSONE 50 MG Oral TabletPSNf40e0a24-b818-42d0-e053-2995a90a91932
198148prednisone 50 MG Oral TabletSCDfd8eb82e-52df-c368-e053-6294a90ac6b02
198148prednisone 50 MG Oral TabletSCDf40e0a24-b818-42d0-e053-2995a90a91932
198148prednisone 50 MG Oral TabletSCD5dde7256-d3b8-400d-a0eb-c60078bfc5d92
198148predniSONE 50 MG Oral TabletPSNfc4e0ebc-f2ee-d335-e053-6394a90a5f201
198148predniSONE 50 MG Oral TabletPSN22d9fd96-cad5-4762-9a56-0ff63357ed9e1
198148predniSONE 50 MG Oral TabletPSN0b25f090-d4da-ee9d-e063-6294a90abbb71
198148prednisone 50 MG Oral TabletSCDfc4e0ebc-f2ee-d335-e053-6394a90a5f201
198148prednisone 50 MG Oral TabletSCD22d9fd96-cad5-4762-9a56-0ff63357ed9e1
198148prednisone 50 MG Oral TabletSCD0b25f090-d4da-ee9d-e063-6294a90abbb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-949-016438009490110 BLISTER PACK in 1 CARTON (64380-949-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2022-05-240000-00-00NoNoCurrent
64380-949-0664380094906100 TABLET in 1 BOTTLE (64380-949-06) 100 tablet2022-05-240000-00-00NoNoCurrent