FDA.reportPublic FDA data

prednisone

Product NDC
64380-785
11-digit product format
643800785
Labeler code
64380
Product ID
64380-785_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
20 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
PREDNISONE20 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
64380-785-01prednisone10 in 1 CARTONTABLET1011
64380-785-01prednisone10 in 1 BLISTER PACKTABLET1011
64380-785-06prednisone100 in 1 BOTTLE, PLASTICTABLET10011
64380-785-07prednisone500 in 1 BOTTLE, PLASTICTABLET50011
64380-785-08prednisone1000 in 1 BOTTLE, PLASTICTABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-785-06EA - Each64380-785137535cc-f0a6-437f-8e9b-1482441f5c2b12021-09-07
64380-785-07EA - Each64380-785afc2afec-4781-44bd-a825-dd2357e6055712021-09-07
64380-785-08EA - Each64380-785d862847d-f3cd-4257-a05f-cc277b5a66ff12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-785PREDNISONE 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
312615predniSONE 20 MG Oral TabletPSN9a2d3bee-610b-44dc-8266-869aaf08f0d1107
312615prednisone 20 MG Oral TabletSCD9a2d3bee-610b-44dc-8266-869aaf08f0d1107
312615predniSONE 20 MG Oral TabletPSN4433a882-ff79-4a9d-8db8-1977c5cd04cf104
312615prednisone 20 MG Oral TabletSCD4433a882-ff79-4a9d-8db8-1977c5cd04cf104
312615predniSONE 20 MG Oral TabletPSNaf5d0f73-2aef-4db1-ae25-6d465c9f0ca117
312615prednisone 20 MG Oral TabletSCDaf5d0f73-2aef-4db1-ae25-6d465c9f0ca117
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
312615predniSONE 20 MG Oral TabletPSN23b12d22-97d6-426e-bf9c-dd6c2ff773708
312615prednisone 20 MG Oral TabletSCD23b12d22-97d6-426e-bf9c-dd6c2ff773708
312615predniSONE 20 MG Oral TabletPSNf6051257-2144-4487-e053-2995a90a973b6
312615predniSONE 20 MG Oral TabletPSNfc4cd6f4-e01f-ad2d-e053-6294a90aebd66
312615prednisone 20 MG Oral TabletSCDf6051257-2144-4487-e053-2995a90a973b6
312615prednisone 20 MG Oral TabletSCDfc4cd6f4-e01f-ad2d-e053-6294a90aebd66
312615predniSONE 20 MG Oral TabletPSNe32609a5-412d-8839-e053-2a95a90a90495
312615prednisone 20 MG Oral TabletSCDe32609a5-412d-8839-e053-2a95a90a90495
198145predniSONE 10 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145predniSONE 10 MG Oral TabletPSN5393d51e-816b-4761-8e8a-7eadcf74245f4
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 TabletSCD5393d51e-816b-4761-8e8a-7eadcf74245f4
198145prednisone 10 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
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 TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
198145predniSONE 10 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
312615predniSONE 20 MG Oral TabletPSN4b37ada5-1f22-46d5-a794-fd1477c0eb9b3
312615predniSONE 20 MG Oral TabletPSN0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615predniSONE 20 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
312617predniSONE 5 MG Oral TabletPSN2d0562ad-6175-833c-e063-6394a90ad0293
198145prednisone 10 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363
198145prednisone 10 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
312615prednisone 20 MG Oral TabletSCD4b37ada5-1f22-46d5-a794-fd1477c0eb9b3
312615prednisone 20 MG Oral TabletSCD0e3d2f62-2b02-4ddf-a983-abb71ff31e363
312615prednisone 20 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
312617prednisone 5 MG Oral TabletSCD2d0562ad-6175-833c-e063-6394a90ad0293
312615predniSONE 20 MG Oral TabletPSNfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52
312615predniSONE 20 MG Oral TabletPSN1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2
312615predniSONE 20 MG Oral TabletPSNf40e8a45-b96a-5fd6-e053-2a95a90ae2e32
312615predniSONE 20 MG Oral TabletPSNe3db385b-0629-fb20-e053-2a95a90ae9012
312615prednisone 20 MG Oral TabletSCDfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52
312615prednisone 20 MG Oral TabletSCDe3db385b-0629-fb20-e053-2a95a90ae9012
312615prednisone 20 MG Oral TabletSCD1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2
312615prednisone 20 MG Oral TabletSCDf40e8a45-b96a-5fd6-e053-2a95a90ae2e32
312615predniSONE 20 MG Oral TabletPSN131780a0-31f3-6588-e063-6294a90a2f8e1
312615predniSONE 20 MG Oral TabletPSNe4437eec-eadf-7c8b-e053-2a95a90af8461
312615prednisone 20 MG Oral TabletSCD131780a0-31f3-6588-e063-6294a90a2f8e1
312615prednisone 20 MG Oral TabletSCDe4437eec-eadf-7c8b-e053-2a95a90af8461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-785-016438007850110 BLISTER PACK in 1 CARTON (64380-785-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2021-09-010000-00-00NoNoCurrent
64380-785-0664380078506100 TABLET in 1 BOTTLE, PLASTIC (64380-785-06) 100 tablet2021-09-010000-00-00NoNoCurrent
64380-785-0764380078507500 TABLET in 1 BOTTLE, PLASTIC (64380-785-07) 500 tablet2021-09-010000-00-00NoNoCurrent
64380-785-08643800785081000 TABLET in 1 BOTTLE, PLASTIC (64380-785-08) 1000 tablet2021-09-010000-00-00NoNoCurrent