Prednisone

Product NDC
54348-506
11-digit product format
543480506
Labeler code
54348
Product ID
54348-506_ea92f170-7889-dd0d-e053-2a95a90a80f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA080356
Marketing category
ANDA
Marketing start
2019-07-12
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2205d503-be51-445b-bb34-c209cc557b3cProduct name520230105
9492a99d-61c8-491f-9086-1c6a7e98c040Product name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54348-506-10Prednisone10 in 1 BOTTLETABLET102
54348-506-10Prednisone1 in 1 BOXTABLET12
54348-506-20Prednisone1 in 1 BOXTABLET12
54348-506-20Prednisone20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-506PREDNISONE TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 4 package rows20221011_03aaf69f-d9c7-433c-baea-9c6eca0fe1e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN03aaf69f-d9c7-433c-baea-9c6eca0fe1e52
198145prednisone 10 MG Oral TabletSCD03aaf69f-d9c7-433c-baea-9c6eca0fe1e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-506-10543480506101 BOTTLE in 1 BOX (54348-506-10) / 10 TABLET in 1 BOTTLE1 bottle2019-07-120000-00-00NoNoCurrent
54348-506-20543480506201 BOTTLE in 1 BOX (54348-506-20) / 20 TABLET in 1 BOTTLE1 bottle2019-07-120000-00-00NoNoCurrent