FDA.reportPublic FDA data

prednisone

Product NDC
64380-835
11-digit product format
643800835
Labeler code
64380
Product ID
64380-835_c389b525-c68a-43dc-bacc-c75707b391b5
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
2.5 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
PREDNISONE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198146, 312617

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
64380-835-01prednisone10 in 1 BLISTER PACKTABLET1010
64380-835-01prednisone10 in 1 CARTONTABLET1010
64380-835-06prednisone100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-835-06EA - Each64380-8354789d21c-d6b0-4240-a9f3-fd0892245afc12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-835PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 3 package rows20250116_52010a34-aadb-4561-ac4a-3ee53f5e3566.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198146predniSONE 2.5 MG Oral TabletPSN07d5e455-ac3b-4890-9619-609dd0be9106104
198146prednisone 2.5 MG Oral TabletSCD07d5e455-ac3b-4890-9619-609dd0be9106104
198146predniSONE 2.5 MG Oral TabletPSN52010a34-aadb-4561-ac4a-3ee53f5e356610
312617predniSONE 5 MG Oral TabletPSN52010a34-aadb-4561-ac4a-3ee53f5e356610
198146prednisone 2.5 MG Oral TabletSCD52010a34-aadb-4561-ac4a-3ee53f5e356610
312617prednisone 5 MG Oral TabletSCD52010a34-aadb-4561-ac4a-3ee53f5e356610
198146predniSONE 2.5 MG Oral TabletPSNd40a97f6-60d1-4dbc-b4dc-650d82af5fae7
198146prednisone 2.5 MG Oral TabletSCDd40a97f6-60d1-4dbc-b4dc-650d82af5fae7
198146predniSONE 2.5 MG Oral TabletPSN930b5eea-3ec8-47df-a76d-1e0bc0b5c5b24
198146prednisone 2.5 MG Oral TabletSCD930b5eea-3ec8-47df-a76d-1e0bc0b5c5b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-835-016438008350110 BLISTER PACK in 1 CARTON (64380-835-01) / 10 TABLET in 1 BLISTER PACK10 blister pack2021-09-010000-00-00NoNoCurrent
64380-835-0664380083506100 TABLET in 1 BOTTLE, PLASTIC (64380-835-06) 100 tablet2021-09-010000-00-00NoNoCurrent