prednisone

Product NDC
0615-8438
11-digit product format
006158438
Labeler code
0615
Product ID
0615-8438_747ce29b-7a16-4275-9462-105f49545e89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
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
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
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
0615-8438-39prednisone30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8438PREDNISONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]1Current NDC, Legacy NDC, 1 package rows20221111_202f6840-f3bd-4bed-ab5d-b36d3c4cdf0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
0615-8438-390061584383930 TABLET in 1 BLISTER PACK (0615-8438-39) 30 tablet2022-11-010000-00-00NoNoCurrent