GLIMEPIRIDE

Product NDC
61919-723
11-digit product format
619190723
Labeler code
61919
Product ID
61919-723_7f80bf43-18af-1b1f-e053-2991aa0ace24
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA078181
Marketing category
ANDA
Marketing start
2019-02-25
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
61919-723-302021-01-29C16284748780-1ba0f9c33-393c-a910-e053-dadaa90a0b85Glimepiride
61919-723-902021-01-29C16284748780-1ba0f9c33-5709-a910-e053-dadaa90a0b85GLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-723-30GLIMEPIRIDE30 in 1 BOTTLETABLET301
61919-723-90GLIMEPIRIDE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-723-30EA - Each61919-72392dd7f07-f4d8-4df1-ba0b-f6e7a706f81a12019-09-05
61919-723-90EA - Each61919-723fe38d74e-d5fc-4563-aa2c-77012a39ab0612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-723GLIMEPIRIDE TABLET [DIRECT RX]1Legacy NDC, 1 package rows20190117_7d652e84-f0ed-0c6f-e053-2a91aa0a0161.zip
61919-723GLIMEPIRIDE TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190302_7f80bf43-18ae-1b1f-e053-2991aa0ace24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN7d652e84-f0ed-0c6f-e053-2a91aa0a01611
199245glimepiride 1 MG Oral TabletPSN7f80bf43-18ae-1b1f-e053-2991aa0ace241
199245glimepiride 1 MG Oral TabletSCD7d652e84-f0ed-0c6f-e053-2a91aa0a01611
199245glimepiride 1 MG Oral TabletSCD7f80bf43-18ae-1b1f-e053-2991aa0ace241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-723-306191907233030 in 1 BOTTLEHistorical
61919-723-906191907239090 in 1 BOTTLEHistorical