prednisone

Product NDC
0615-8440
11-digit product format
006158440
Labeler code
0615
Product ID
0615-8440_d607202d-61e1-4a93-8456-04833ad570ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prednisone
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA213386
Marketing category
ANDA
Marketing start
2020-06-24
Substance
PREDNISONE
Active strength
10 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
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 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
0615-8440-05prednisone15 in 1 BLISTER PACKTABLET155
0615-8440-39prednisone30 in 1 BLISTER PACKTABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8440PREDNISONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]5Current NDC, Legacy NDC, 2 package rows20240814_7b60255f-7d0b-4f91-a75c-6682ac446f6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615predniSONE 20 MG Oral TabletPSN7b60255f-7d0b-4f91-a75c-6682ac446f6b5
198145prednisone 10 MG Oral TabletSCD7b60255f-7d0b-4f91-a75c-6682ac446f6b5
312615prednisone 20 MG Oral TabletSCD7b60255f-7d0b-4f91-a75c-6682ac446f6b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8440-050061584400515 TABLET in 1 BLISTER PACK (0615-8440-05) 15 tablet2022-10-270000-00-00NoNoCurrent
0615-8440-390061584403930 TABLET in 1 BLISTER PACK (0615-8440-39) 30 tablet2022-10-270000-00-00NoNoCurrent