FDA.reportPublic FDA data

Prednisone

Product NDC
72789-401
11-digit product format
727890401
Labeler code
72789
Product ID
72789-401_2e815bd0-baeb-9631-e063-6394a90a49c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA211575
Marketing category
ANDA
Marketing start
2019-11-15
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
205c2cdd-a63b-cbc9-6bcb-6be6001edf81Product name220170705

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72789-401-10Prednisone10 in 1 BOTTLE, PLASTICTABLET1013
72789-401-12Prednisone12 in 1 BOTTLE, PLASTICTABLET1213
72789-401-20Prednisone20 in 1 BOTTLE, PLASTICTABLET2013
72789-401-21Prednisone21 in 1 BOTTLE, PLASTICTABLET2113
72789-401-30Prednisone30 in 1 BOTTLE, PLASTICTABLET3013
72789-401-40Prednisone40 in 1 BOTTLE, PLASTICTABLET4013
72789-401-42Prednisone42 in 1 BOTTLE, PLASTICTABLET4213
72789-401-50Prednisone50 in 1 BOTTLE, PLASTICTABLET5013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-401-10EA - Each72789-40193a3ea9b-a0e1-44b4-ba3a-8818a620a82c12024-07-12
72789-401-12EA - Each72789-4011bbfdc33-6ee4-4d77-a981-21d391a1b2b612024-08-12
72789-401-20EA - Each72789-4010396a0ac-5a07-4174-830d-af4c6d3fe0aa12024-08-12
72789-401-21EA - Each72789-401e5e9f336-7321-42fd-b80d-938eabec17c012024-08-12
72789-401-30EA - Each72789-40112c78788-8eb9-452d-8bc4-2f215fc0359a12024-07-12
72789-401-40EA - Each72789-40150522d46-8083-40ee-a084-b82dd20b4e7c12024-07-12
72789-401-50EA - Each72789-401e346a9a8-fab2-4351-bb28-0988dee0c19412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-401PREDNISONE TABLET [PD-RX PHARMACEUTICALS, INC.]13Current NDC, 8 package rows20250221_19fdbf9f-3a64-b9fa-e063-6394a90af086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSN19fdbf9f-3a64-b9fa-e063-6394a90af08613
198145prednisone 10 MG Oral TabletSCD19fdbf9f-3a64-b9fa-e063-6394a90af08613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-401-107278904011010 TABLET in 1 BOTTLE, PLASTIC (72789-401-10) 10 tablet2024-06-04NoNoCurrent
72789-401-127278904011212 TABLET in 1 BOTTLE, PLASTIC (72789-401-12) 12 tablet2024-07-10NoNoCurrent
72789-401-207278904012020 TABLET in 1 BOTTLE, PLASTIC (72789-401-20) 20 tablet2024-06-20NoNoCurrent
72789-401-217278904012121 TABLET in 1 BOTTLE, PLASTIC (72789-401-21) 21 tablet2024-06-25NoNoCurrent
72789-401-307278904013030 TABLET in 1 BOTTLE, PLASTIC (72789-401-30) 30 tablet2024-06-03NoNoCurrent
72789-401-407278904014040 TABLET in 1 BOTTLE, PLASTIC (72789-401-40) 40 tablet2024-06-03NoNoCurrent
72789-401-427278904014242 TABLET in 1 BOTTLE, PLASTIC (72789-401-42) 42 tablet2025-01-10NoNoCurrent
72789-401-507278904015050 TABLET in 1 BOTTLE, PLASTIC (72789-401-50) 50 tablet2024-06-03NoNoCurrent