FDA.reportPublic FDA data

PREDNISONE

Product NDC
61919-108
11-digit product format
619190108
Labeler code
61919
Product ID
61919-108_e9d1c394-3003-1420-e053-2995a90a1f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040362
Marketing category
ANDA
Marketing start
2019-08-07
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
20 mg/1
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-108-102025-01-30C16284748780-12cef2736-7768-d83d-e063-dadaa90ab31fPREDNISONE
61919-108-122025-01-30C16284748780-12cef2736-7768-d83d-e063-dadaa90ab31fPREDNISONE
61919-108-142025-01-30C16284748780-12cef2736-7768-d83d-e063-dadaa90ab31fPREDNISONE
61919-108-152025-01-30C16284748780-12cef2736-7768-d83d-e063-dadaa90ab31fPREDNISONE
61919-108-202025-01-30C16284748780-12cef2736-7768-d83d-e063-dadaa90ab31fPREDNISONE
61919-108-302025-01-30C16284748780-12cef2736-6ac7-d83d-e063-dadaa90ab31fPREDNISONE 20mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-108-30PREDNISONE30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-108-10EA - Each61919-108cfba968b-1acb-4b8f-a73c-00ccd1d1b2c212023-09-05
61919-108-12EA - Each61919-1084013aa58-4c9f-48f3-b05b-11f8b36bc80612019-09-05
61919-108-14EA - Each61919-1080417e81c-d4be-4d87-b33c-26128ab58ebd12019-09-05
61919-108-21EA - Each61919-108052843c9-7c43-43fe-b3d4-b165ee7d231912026-03-17
61919-108-30EA - Each61919-1086f9df63c-2248-42ff-b719-8a56f2aea7d412019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-108PREDNISONE TABLET [DIRECT_RX]7Legacy NDC20230829_8f8cc19a-0815-d3ed-e053-2995a90a4e9c.zip
61919-108PREDNISONE TABLET [DIRECT RX]1Legacy NDC, 1 package rows20190410_83e76d04-cba2-5aee-e053-2a91aa0add6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSN83e76d04-cba2-5aee-e053-2a91aa0add6a1
312615prednisone 20 MG Oral TabletSCD83e76d04-cba2-5aee-e053-2a91aa0add6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-108-106191901081010 TABLET in 1 BOTTLE (61919-108-10) 10 tablet2019-08-070000-00-00NoNoCurrent
61919-108-126191901081212 TABLET in 1 BOTTLE (61919-108-12) 12 tablet2019-08-070000-00-00NoNoCurrent
61919-108-146191901081414 TABLET in 1 BOTTLE (61919-108-14) 14 tablet2019-08-070000-00-00NoNoCurrent
61919-108-156191901081515 TABLET in 1 BOTTLE (61919-108-15) 15 tablet2019-08-070000-00-00NoNoCurrent
61919-108-206191901082020 TABLET in 1 BOTTLE (61919-108-20) 20 tablet2019-08-070000-00-00NoNoCurrent
61919-108-306191901083030 TABLET in 1 BOTTLE (61919-108-30) 30 tablet2019-04-080000-00-00NoNoCurrent