PredniSONE

Product NDC
70934-831
11-digit product format
709340831
Labeler code
70934
Product ID
70934-831_c07cf3f2-e104-15c5-e053-2995a90a3ef6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PredniSONE
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA084122
Marketing category
ANDA
Marketing start
2021-02-25
Marketing end
0000-00-00
Substance
PREDNISONE
Active strength
10 mg/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-831-102023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-122023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-152023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-202023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-212023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-302023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-402023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-422023-02-06C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-102023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-122023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-152023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-202023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-212023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-302023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-402023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6
70934-831-422023-01-30C16284748780-1f386c649-f7b6-0266-e053-dadaa90a7c1abc3e9035-803f-d3aa-e053-2a95a90adbc6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-831-12EA - Each70934-83145f027f2-d5c0-4f3c-b655-be39945b130112023-01-09
70934-831-15EA - Each70934-8318767e081-c9b4-4656-a138-efc44449d46312023-01-09
70934-831-21EA - Each70934-831ec7bec3b-8692-4efa-b968-1a4b75fa365a12023-01-09
70934-831-30EA - Each70934-8313ac255c0-a849-471f-b095-6566e379c97312023-01-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-831-107093408311010 TABLET in 1 BOTTLE, PLASTIC (70934-831-10) 10 tablet2021-03-250000-00-00NoNoCurrent
70934-831-127093408311212 TABLET in 1 BOTTLE, PLASTIC (70934-831-12) 12 tablet2021-03-240000-00-00NoNoCurrent
70934-831-157093408311515 TABLET in 1 BOTTLE, PLASTIC (70934-831-15) 15 tablet2021-03-250000-00-00NoNoCurrent
70934-831-207093408312020 TABLET in 1 BOTTLE, PLASTIC (70934-831-20) 20 tablet2021-04-210000-00-00NoNoCurrent
70934-831-217093408312121 TABLET in 1 BOTTLE, PLASTIC (70934-831-21) 21 tablet2021-02-250000-00-00NoNoCurrent
70934-831-307093408313030 TABLET in 1 BOTTLE, PLASTIC (70934-831-30) 30 tablet2021-03-250000-00-00NoNoCurrent
70934-831-407093408314040 TABLET in 1 BOTTLE, PLASTIC (70934-831-40) 40 tablet2021-07-160000-00-00NoNoCurrent
70934-831-427093408314242 TABLET in 1 BOTTLE, PLASTIC (70934-831-42) 42 tablet2021-03-240000-00-00NoNoCurrent