FDA.reportPublic FDA data

PREDNISONE

Product NDC
61919-326
11-digit product format
619190326
Labeler code
61919
Product ID
61919-326_f2127f51-a0aa-9fe2-e053-2a95a90a8cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREDNISONE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA080356
Marketing category
ANDA
Marketing start
2014-01-01
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
2024-12-31
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
61919-326-052025-01-30C16284748780-12cef2736-695b-d83d-e063-dadaa90ab31fPREDNISONE
61919-326-212025-01-30C16284748780-12cef2736-695b-d83d-e063-dadaa90ab31fPREDNISONE
61919-326-302025-01-30C16284748780-12cef2736-695b-d83d-e063-dadaa90ab31fPREDNISONE
61919-326-102023-01-30C16284748780-1f386c64a-352d-0266-e053-dadaa90a7c1aPREDNISONE
61919-326-152023-01-30C16284748780-1f386c64a-22cd-0266-e053-dadaa90a7c1aPREDNISONE
61919-326-202023-01-30C16284748780-1f386c649-d79c-0266-e053-dadaa90a7c1aPREDNISONE
61919-326-232023-01-30C16284748780-1f386c64a-0c72-0266-e053-dadaa90a7c1aPREDNISONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-326-05PREDNISONE5 in 1 BLISTER PACKTABLET59
61919-326-21PREDNISONE21 in 1 BOTTLETABLET219
61919-326-30PREDNISONE30 in 1 BOTTLETABLET309
61919-326-10PREDNISONE10 in 1 BOTTLETABLET101
61919-326-15PREDNISONE15 in 1 BOTTLETABLET151
61919-326-20PREDNISONE20 in 1 BOTTLETABLET201
61919-326-23PREDNISONE23 in 1 BOTTLETABLET231

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-326-05EA - Each61919-326031d9661-d04f-46cd-acd9-81fd6a87899f12022-10-06
61919-326-10EA - Each61919-326f95f94c9-8c97-4463-827a-ce53a24e681512019-09-05
61919-326-15EA - Each61919-326b685e592-3c41-4440-8b6b-a8b05b2c198212019-10-07
61919-326-20EA - Each61919-32670fc73c6-3019-40c5-b63d-566d6492dbdd12019-10-07
61919-326-21EA - Each61919-3263c0cd173-8bc9-49b6-9226-269d1ac126d612014-07-02
61919-326-23EA - Each61919-326c1446ea1-e74c-4df2-b1d3-7f55b755553112019-09-05
61919-326-30EA - Each61919-32626150596-03eb-4c76-a82f-2d6d8cda67b012022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PREDNISONEACTIVE INGREDIENTVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
PREDNISONEACTIVE MOIETYVB0R961HZTPREDNISONE TABLET [DIRECT RX]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREDNISONE TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREDNISONE TABLET [DIRECT RX]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPREDNISONE TABLET [DIRECT RX]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0PREDNISONE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREDNISONE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREDNISONE TABLET [DIRECT RX]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPREDNISONE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-326PREDNISONE TABLET [DIRECT_RX]9Legacy NDC, 3 package rows20230420_d9b1652b-820a-4971-ab71-58bd55908b4d.zip
61919-326PREDNISONE TABLET [DIECT_RX]1Legacy NDC, 1 package rows20190808_8f8cc292-4417-0a3b-e053-2a95a90ace3a.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190724_8e6dceeb-132f-f12d-e053-2995a90a2241.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190906_91ce3df8-9d2b-5479-e053-2a95a90aab84.zip
61919-326PREDNISONE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190917_92ad0264-035e-b12a-e053-2a95a90a684e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312615predniSONE 20 MG Oral TabletPSNd9b1652b-820a-4971-ab71-58bd55908b4d9
312615prednisone 20 MG Oral TabletSCDd9b1652b-820a-4971-ab71-58bd55908b4d9
312615predniSONE 20 MG Oral TabletPSN8e6dceeb-132f-f12d-e053-2995a90a22411
312615predniSONE 20 MG Oral TabletPSN8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615predniSONE 20 MG Oral TabletPSN91ce3df8-9d2b-5479-e053-2a95a90aab841
312615predniSONE 20 MG Oral TabletPSN92ad0264-035e-b12a-e053-2a95a90a684e1
312615prednisone 20 MG Oral TabletSCD8e6dceeb-132f-f12d-e053-2995a90a22411
312615prednisone 20 MG Oral TabletSCD8f8cc292-4417-0a3b-e053-2a95a90ace3a1
312615prednisone 20 MG Oral TabletSCD91ce3df8-9d2b-5479-e053-2a95a90aab841
312615prednisone 20 MG Oral TabletSCD92ad0264-035e-b12a-e053-2a95a90a684e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-326-05619190326055 TABLET in 1 BLISTER PACK (61919-326-05) 5 tablet2014-01-010000-00-00NoNoCurrent
61919-326-106191903261010 TABLET in 1 BOTTLE (61919-326-10) 10 tablet2019-07-240000-00-00NoNoCurrent
61919-326-156191903261515 TABLET in 1 BOTTLE (61919-326-15) 15 tablet2019-09-050000-00-00NoNoCurrent
61919-326-206191903262020 TABLET in 1 BOTTLE (61919-326-20) 20 tablet2019-09-160000-00-00NoNoCurrent
61919-326-216191903262121 TABLET in 1 BOTTLE (61919-326-21) 21 tablet2019-09-180000-00-00NoNoCurrent
61919-326-236191903262323 TABLET in 1 BOTTLE (61919-326-23) 23 tablet2019-08-070000-00-00NoNoCurrent
61919-326-306191903263030 TABLET in 1 BOTTLE (61919-326-30) 30 tablet2022-09-190000-00-00NoNoCurrent