FDA.reportPublic FDA data

prednisone

Product NDC
76420-412
11-digit product format
764200412
Labeler code
76420
Product ID
76420-412_4c2b2c5f-3f84-9799-e063-6294a90a37cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA208412
Marketing category
ANDA
Marketing start
2021-09-01
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prednisone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREDNISONE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVB0R961HZT
Rxcui198145, 198148, 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
76420-412-00prednisone1000 in 1 BOTTLE, PLASTICTABLET10004
76420-412-01prednisone100 in 1 BOTTLE, PLASTICTABLET1004
76420-412-05prednisone5 in 1 BOTTLE, PLASTICTABLET54
76420-412-10prednisone10 in 1 BOTTLE, PLASTICTABLET104
76420-412-18prednisone18 in 1 BOTTLE, PLASTICTABLET184
76420-412-20prednisone20 in 1 BOTTLE, PLASTICTABLET204
76420-412-21prednisone21 in 1 BOTTLE, PLASTICTABLET214
76420-412-30prednisone30 in 1 BOTTLE, PLASTICTABLET304
76420-412-50prednisone500 in 1 BOTTLE, PLASTICTABLET5004
76420-412-60prednisone60 in 1 BOTTLE, PLASTICTABLET604
76420-412-90prednisone90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-412-00EA - Each76420-41217a0e2d9-ea4e-41de-a3c7-e79e6c38008612026-03-17
76420-412-01EA - Each76420-412f3d51d48-307d-4c22-82b1-977fde4226bf12026-03-17
76420-412-05EA - Each76420-41219c9915d-7c58-4fae-bb82-4b40969c882c12026-03-17
76420-412-10EA - Each76420-412ae1c26ee-3937-4a8f-bc07-eb4402f60fbf12026-03-17
76420-412-18EA - Each76420-4121f0162a7-bddd-48f7-b003-010148fe53a312026-03-17
76420-412-20EA - Each76420-4121e88c5a2-7051-4c69-8f8c-a3ce6ea68ab512026-03-17
76420-412-21EA - Each76420-4125a239337-e9e3-4de3-88aa-6627a8c7380112026-03-17
76420-412-30EA - Each76420-412887ba70f-6156-4089-acb0-290ace4c3fce12026-03-17
76420-412-50EA - Each76420-412a70957ca-80fa-4d19-b257-15d015142e8a12026-03-17
76420-412-60EA - Each76420-412a1119c97-fa9e-4c7c-a1da-abac8d78ace112026-03-17
76420-412-90EA - Each76420-412fa751a07-846f-4c54-b946-850d8b20a86012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615predniSONE 20 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148predniSONE 50 MG Oral TabletPSNfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198145prednisone 10 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
312615prednisone 20 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374
198148prednisone 50 MG Oral TabletSCDfdcf3271-fae7-47ef-a370-adbdc0a3cf374

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-412-00764200412001000 TABLET in 1 BOTTLE, PLASTIC (76420-412-00) 1000 tablet2025-07-09NoNoCurrent
76420-412-0176420041201100 TABLET in 1 BOTTLE, PLASTIC (76420-412-01) 100 tablet2025-07-09NoNoCurrent
76420-412-05764200412055 TABLET in 1 BOTTLE, PLASTIC (76420-412-05) 5 tablet2025-07-09NoNoCurrent
76420-412-107642004121010 TABLET in 1 BOTTLE, PLASTIC (76420-412-10) 10 tablet2026-01-24NoNoCurrent
76420-412-187642004121818 TABLET in 1 BOTTLE, PLASTIC (76420-412-18) 18 tablet2025-07-09NoNoCurrent
76420-412-207642004122020 TABLET in 1 BOTTLE, PLASTIC (76420-412-20) 20 tablet2025-07-09NoNoCurrent
76420-412-217642004122121 TABLET in 1 BOTTLE, PLASTIC (76420-412-21) 21 tablet2026-01-28NoNoCurrent
76420-412-307642004123030 TABLET in 1 BOTTLE, PLASTIC (76420-412-30) 30 tablet2025-07-09NoNoCurrent
76420-412-5076420041250500 TABLET in 1 BOTTLE, PLASTIC (76420-412-50) 500 tablet2025-07-09NoNoCurrent
76420-412-607642004126060 TABLET in 1 BOTTLE, PLASTIC (76420-412-60) 60 tablet2025-07-09NoNoCurrent
76420-412-907642004129090 TABLET in 1 BOTTLE, PLASTIC (76420-412-90) 90 tablet2025-07-09NoNoCurrent