GLIMEPIRIDE

Product NDC
61919-250
11-digit product format
619190250
Labeler code
61919
Product ID
61919-250_f2030f1c-9993-4b65-e053-2995a90ac5eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078181
Marketing category
ANDA
Marketing start
2016-02-04
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [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
b890b964-2cf0-4439-aaf3-900c9e3e9e49Product name120160602
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
d36d861f-8a90-80cc-8935-1e6be9b4c7ebProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-250-042025-01-30C16284748780-12cef2736-5f1e-d83d-e063-dadaa90ab31fGLIMEPIRIDE
61919-250-302025-01-30C16284748780-12cef2736-5f1e-d83d-e063-dadaa90ab31fGLIMEPIRIDE
61919-250-602025-01-30C16284748780-12cef2736-5f1e-d83d-e063-dadaa90ab31fGLIMEPIRIDE
61919-250-822025-01-30C16284748780-12cef2736-5f1e-d83d-e063-dadaa90ab31fGLIMEPIRIDE
61919-250-902025-01-30C16284748780-12cef2736-5f1e-d83d-e063-dadaa90ab31fGLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-250-04GLIMEPIRIDE4 in 1 BOTTLETABLET43
61919-250-30GLIMEPIRIDE30 in 1 BOTTLETABLET303
61919-250-60GLIMEPIRIDE60 in 1 BOTTLETABLET603
61919-250-82GLIMEPIRIDE180 in 1 BOTTLETABLET1803
61919-250-90GLIMEPIRIDE90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-250-04EA - Each61919-2502601b77b-4655-42b5-8fd3-912022b281af12019-12-10
61919-250-30EA - Each61919-250e266c593-4301-43b8-ad88-0500b79137ad12019-12-10
61919-250-60EA - Each61919-250d940960e-fe9c-4260-8dd0-d8093e59163312019-12-10
61919-250-82EA - Each61919-2502fb0de70-2a6d-4239-a4df-af2c74796c5a12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-250GLIMEPIRIDE TABLET [DIRECT RX]3Legacy NDC, 5 package rows20230113_2b57dfa7-f2c2-45ca-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN2b57dfa7-f2c2-45ca-e054-00144ff8d46c3
199247glimepiride 4 MG Oral TabletSCD2b57dfa7-f2c2-45ca-e054-00144ff8d46c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-250-04619190250044 TABLET in 1 BOTTLE (61919-250-04) 4 tablet2016-02-040000-00-00NoNoCurrent
61919-250-306191902503030 TABLET in 1 BOTTLE (61919-250-30) 30 tablet2016-02-040000-00-00NoNoCurrent
61919-250-606191902506060 TABLET in 1 BOTTLE (61919-250-60) 60 tablet2016-02-040000-00-00NoNoCurrent
61919-250-8261919025082180 TABLET in 1 BOTTLE (61919-250-82) 180 tablet2016-02-040000-00-00NoNoCurrent
61919-250-906191902509090 TABLET in 1 BOTTLE (61919-250-90) 90 tablet2016-02-040000-00-00NoNoCurrent