FDA.reportPublic FDA data

Prednisone

Product NDC
80425-0105
11-digit product format
804250105
Labeler code
80425
Product ID
80425-0105_2a99a80e-d067-27e6-e063-6294a90ae0fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA040362
Marketing category
ANDA
Marketing start
2001-08-29
Substance
PREDNISONE
Active strength
20 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
PREDNISONE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui312615

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
80425-0105-1Prednisone20 in 1 BOTTLETABLET207
80425-0105-2Prednisone10 in 1 BOTTLETABLET107
80425-0105-3Prednisone15 in 1 BOTTLETABLET157

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0105-1EA - Each80425-010558e8e305-d494-41c5-9ce1-ab4a5a0d675612023-06-06
80425-0105-2EA - Each80425-010588a2879b-dffa-47ef-bd0a-aa562df6862612023-06-06
80425-0105-3EA - Each80425-01057a9c4253-0067-4160-b575-d8032b4c2f4f12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0105PREDNISONE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20250101_b3dbff9f-610f-7782-e053-2a95a90a71c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNb3dbff9f-610f-7782-e053-2a95a90a71c17
312615prednisone 20 MG Oral TabletSCDb3dbff9f-610f-7782-e053-2a95a90a71c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0105-18042501050120 TABLET in 1 BOTTLE (80425-0105-1) 20 tablet2001-08-290000-00-00NoNoCurrent
80425-0105-28042501050210 TABLET in 1 BOTTLE (80425-0105-2) 10 tablet2023-03-30NoNoHistorical
80425-0105-38042501050315 TABLET in 1 BOTTLE (80425-0105-3) 15 tablet2023-05-16NoNoHistorical