FDA.reportPublic FDA data

prednisone

Product NDC
76420-413
11-digit product format
764200413
Labeler code
76420
Product ID
76420-413_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
20 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
PREDNISONE20 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
76420-413-00prednisone1000 in 1 BOTTLE, PLASTICTABLET10004
76420-413-01prednisone100 in 1 BOTTLE, PLASTICTABLET1004
76420-413-05prednisone5 in 1 BOTTLE, PLASTICTABLET54
76420-413-10prednisone10 in 1 BOTTLE, PLASTICTABLET104
76420-413-18prednisone18 in 1 BOTTLE, PLASTICTABLET184
76420-413-20prednisone20 in 1 BOTTLE, PLASTICTABLET204
76420-413-21prednisone21 in 1 BOTTLE, PLASTICTABLET214
76420-413-30prednisone30 in 1 BOTTLE, PLASTICTABLET304
76420-413-50prednisone500 in 1 BOTTLE, PLASTICTABLET5004
76420-413-60prednisone60 in 1 BOTTLE, PLASTICTABLET604
76420-413-90prednisone90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-413-00EA - Each76420-413fb9808d0-1be4-48b0-8e27-e0003babf18712026-03-17
76420-413-01EA - Each76420-413da6a010c-8ba4-44da-ab47-93bd8abb7b7a12026-03-17
76420-413-05EA - Each76420-413777e732e-3d4a-419a-830f-07148ebedada12026-03-17
76420-413-10EA - Each76420-41338858a05-dd9f-4872-bd60-fbb8b56efcae12026-03-17
76420-413-18EA - Each76420-41360e51651-f5a0-4c65-9dd5-bbdee4a468f012026-03-17
76420-413-20EA - Each76420-413c0f2ec8e-fa22-4ce9-aee1-1388178361ce12026-03-17
76420-413-21EA - Each76420-41386136c1b-031e-45a9-acfc-06806e51892f12026-03-17
76420-413-30EA - Each76420-4137b1ae652-a465-4847-ae8e-b8582a7c8d7912026-04-20
76420-413-50EA - Each76420-413eaf0abca-9572-4360-b445-48f0d1f877f612026-03-17
76420-413-60EA - Each76420-413ed06b99e-8f37-456c-8776-15ed89c08eb012026-03-17
76420-413-90EA - Each76420-4139a4fd6e1-c5f4-47fa-b29e-c0c1194649cf12026-03-17

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
76420-413-00764200413001000 TABLET in 1 BOTTLE, PLASTIC (76420-413-00) 1000 tablet2025-07-09NoNoHistorical
76420-413-0176420041301100 TABLET in 1 BOTTLE, PLASTIC (76420-413-01) 100 tablet2025-07-09NoNoHistorical
76420-413-05764200413055 TABLET in 1 BOTTLE, PLASTIC (76420-413-05) 5 tablet2025-07-09NoNoHistorical
76420-413-107642004131010 TABLET in 1 BOTTLE, PLASTIC (76420-413-10) 10 tablet2026-01-24NoNoHistorical
76420-413-187642004131818 TABLET in 1 BOTTLE, PLASTIC (76420-413-18) 18 tablet2025-07-09NoNoHistorical
76420-413-207642004132020 TABLET in 1 BOTTLE, PLASTIC (76420-413-20) 20 tablet2025-07-09NoNoHistorical
76420-413-217642004132121 TABLET in 1 BOTTLE, PLASTIC (76420-413-21) 21 tablet2026-01-28NoNoHistorical
76420-413-307642004133030 TABLET in 1 BOTTLE, PLASTIC (76420-413-30) 30 tablet2025-07-09NoNoHistorical
76420-413-5076420041350500 TABLET in 1 BOTTLE, PLASTIC (76420-413-50) 500 tablet2025-07-09NoNoHistorical
76420-413-607642004136060 TABLET in 1 BOTTLE, PLASTIC (76420-413-60) 60 tablet2025-07-09NoNoHistorical
76420-413-907642004139090 TABLET in 1 BOTTLE, PLASTIC (76420-413-90) 90 tablet2025-07-09NoNoHistorical