FDA.reportPublic FDA data

Prednisone

Product NDC
0378-0642
11-digit product format
003780642
Labeler code
0378
Product ID
0378-0642_f7cba7fb-7b9f-4464-a702-5c4f818aeb5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisone
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA083677
Marketing category
ANDA
Marketing start
2020-02-06
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
Rxcui198145, 312615, 312617

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0378-0642-01Prednisone100 in 1 BOTTLE, PLASTICTABLET1009
0378-0642-05Prednisone500 in 1 BOTTLE, PLASTICTABLET5009
0378-0642-10Prednisone1000 in 1 BOTTLE, PLASTICTABLET10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0642-01EA - Each0378-0642ca645489-25c1-483b-837f-33ed8694ee3412020-03-10
0378-0642-05EA - Each0378-0642e09d301e-942d-4109-83dd-1c5d87e5e87412020-03-10
0378-0642-10EA - Each0378-0642c47091e6-e888-46c7-9e5e-af3ed8008e8a12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0642PREDNISONE TABLET [MYLAN PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 3 package rows20250221_fec09050-5ac2-451b-a2b9-5a21b2def212.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198145predniSONE 10 MG Oral TabletPSNfec09050-5ac2-451b-a2b9-5a21b2def2129
312615predniSONE 20 MG Oral TabletPSNfec09050-5ac2-451b-a2b9-5a21b2def2129
312617predniSONE 5 MG Oral TabletPSNfec09050-5ac2-451b-a2b9-5a21b2def2129
198145prednisone 10 MG Oral TabletSCDfec09050-5ac2-451b-a2b9-5a21b2def2129
312615prednisone 20 MG Oral TabletSCDfec09050-5ac2-451b-a2b9-5a21b2def2129
312617prednisone 5 MG Oral TabletSCDfec09050-5ac2-451b-a2b9-5a21b2def2129
198145predniSONE 10 MG Oral TabletPSN1e05e071-0407-0970-e063-6294a90a6c652
312615predniSONE 20 MG Oral TabletPSN1e05e071-0407-0970-e063-6294a90a6c652
312615predniSONE 20 MG Oral TabletPSNf40ec393-959b-3e89-e053-2a95a90a95912
312617predniSONE 5 MG Oral TabletPSN1e05e071-0407-0970-e063-6294a90a6c652
198145prednisone 10 MG Oral TabletSCD1e05e071-0407-0970-e063-6294a90a6c652
312615prednisone 20 MG Oral TabletSCD1e05e071-0407-0970-e063-6294a90a6c652
312615prednisone 20 MG Oral TabletSCDf40ec393-959b-3e89-e053-2a95a90a95912
312617prednisone 5 MG Oral TabletSCD1e05e071-0407-0970-e063-6294a90a6c652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0642-0100378064201100 TABLET in 1 BOTTLE, PLASTIC (0378-0642-01) 100 tablet2020-02-110000-00-00NoNoCurrent
0378-0642-0500378064205500 TABLET in 1 BOTTLE, PLASTIC (0378-0642-05) 500 tablet2020-02-060000-00-00NoNoCurrent
0378-0642-10003780642101000 TABLET in 1 BOTTLE, PLASTIC (0378-0642-10) 1000 tablet2020-02-110000-00-00NoNoCurrent