prednisone

Product NDC
0615-8439
11-digit product format
006158439
Labeler code
0615
Product ID
0615-8439_cdfb3f3c-f9c8-402c-933d-c2bf6600b213
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA213385
Marketing category
ANDA
Marketing start
2021-08-04
Substance
PREDNISONE
Active strength
5 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312617

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
0615-8439-05prednisone15 in 1 BLISTER PACKTABLET151
0615-8439-39prednisone30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8439PREDNISONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, Legacy NDC, 2 package rows20221112_bc37cc2e-2f6a-4131-bb6a-63b6e576df21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312617predniSONE 5 MG Oral TabletPSNbc37cc2e-2f6a-4131-bb6a-63b6e576df211
312617prednisone 5 MG Oral TabletSCDbc37cc2e-2f6a-4131-bb6a-63b6e576df211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8439-050061584390515 TABLET in 1 BLISTER PACK (0615-8439-05) 15 tablet2022-10-060000-00-00NoNoCurrent
0615-8439-390061584393930 TABLET in 1 BLISTER PACK (0615-8439-39) 30 tablet2022-10-060000-00-00NoNoCurrent