FDA.reportPublic FDA data

GLIMEPIRIDE

Product NDC
61919-448
11-digit product format
619190448
Labeler code
61919
Product ID
61919-448_d61cab38-675c-37ab-e053-2a95a90a4f91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIMEPIRIDE
Dosage form
TABLET
Route
ORAL
Labeler
Dircet_Rx
Application
ANDA078181
Marketing category
ANDA
Marketing start
2019-08-08
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
2 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [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
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
61919-448-302022-01-28C16284748780-1d6a99b39-d3b2-a426-e053-dadaa90af4c2GLIMEPIRIDE
61919-448-602020-01-31C16284748780-19d75b9d0-abca-f424-e053-dadaa90a57ceGLIMEPIRIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-448-30GLIMEPIRIDE30 in 1 BOTTLETABLET302
61919-448-60GLIMEPIRIDE60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-448-30EA - Each61919-4481cbb957d-4d2b-40d0-9961-7268a09e5bcc12019-09-05
61919-448-90EA - Each61919-448dc44c911-6525-44f7-96a7-e7ce29d1b61712019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [DIRECTRX]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKGLIMEPIRIDE TABLET [DIRECTRX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIMEPIRIDE TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [DIRECTRX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-448GLIMEPIRIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200121_8f9cce0a-1054-3c21-e053-2a95a90a8b87.zip
61919-448GLIMEPIRIDE TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151125_254e279f-c852-1197-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN8f9cce0a-1054-3c21-e053-2a95a90a8b872
199246glimepiride 2 MG Oral TabletSCD8f9cce0a-1054-3c21-e053-2a95a90a8b872
199246glimepiride 2 MG Oral TabletPSN254e279f-c852-1197-e054-00144ff8d46c1
199246glimepiride 2 MG Oral TabletSCD254e279f-c852-1197-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-448-306191904483030 TABLET in 1 BOTTLE (61919-448-30) 30 tablet2019-08-080000-00-00NoNoCurrent
61919-448-606191904486060 in 1 BOTTLEHistorical
61919-448-906191904489090 TABLET in 1 BOTTLE (61919-448-90) 90 tablet2019-08-080000-00-00NoNoCurrent