prednisone

Product NDC
64380-782
11-digit product format
643800782
Labeler code
64380
Product ID
64380-782_675efef2-fa13-42d1-9460-d1e334f78a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA210785
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
1 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
PREDNISONE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198144

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
64380-782-06prednisone100 in 1 BOTTLE, PLASTICTABLET10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-782-06EA - Each64380-782eafcfc32-074a-4ed6-a1be-f6aeb40f1a7412021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-782PREDNISONE TABLET [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 1 package rows20240316_a2c2e8ee-d222-47c5-93c2-8b44160a7e48.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198144predniSONE 1 MG Oral TabletPSNa2c2e8ee-d222-47c5-93c2-8b44160a7e4810
198144prednisone 1 MG Oral TabletSCDa2c2e8ee-d222-47c5-93c2-8b44160a7e4810
198144predniSONE 1 MG Oral TabletPSN202f6840-f3bd-4bed-ab5d-b36d3c4cdf0f1
198144prednisone 1 MG Oral TabletSCD202f6840-f3bd-4bed-ab5d-b36d3c4cdf0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-782-0664380078206100 TABLET in 1 BOTTLE, PLASTIC (64380-782-06) 100 tablet2021-09-010000-00-00NoNoCurrent