FDA.reportPublic FDA data

GLIPIZIDE

Product NDC
61919-287
11-digit product format
619190287
Labeler code
61919
Product ID
61919-287_ceb46d21-68c2-bd34-e053-2a95a90acb1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLIPIZIDE
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075795
Marketing category
ANDA
Marketing start
2019-08-20
Marketing end
0000-00-00
Substance
GLIPIZIDE
Active strength
10 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec4adfb0-aabc-95b9-ad07-5cb8f8533a09Product name220250625
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-287-302025-01-30C16284748780-12cef2736-89f7-d83d-e063-dadaa90ab31fGLIPIZIDE
61919-287-602025-01-30C16284748780-12cef2736-89f7-d83d-e063-dadaa90ab31fGLIPIZIDE
61919-287-822025-01-30C16284748780-12cef2736-8af3-d83d-e063-dadaa90ab31fGLIPIZIDE
61919-287-902025-01-30C16284748780-19d75b9cf-fd61-f424-e053-dadaa90a57ceGLIPIZIDE
61919-287-902021-01-07C16284748780-19d75b9cf-fd61-f424-e053-dadaa90a57ceGLIPIZIDE
61919-287-902020-01-31C16284748780-19d75b9cf-fd61-f424-e053-dadaa90a57ceGLIPIZIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-287-30GLIPIZIDE30 in 1 BOTTLETABLET304
61919-287-60GLIPIZIDE60 in 1 BOTTLETABLET604
61919-287-82GLIPIZIDE180 in 1 BOTTLETABLET1802
61919-287-90GLIPIZIDE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-287-30EA - Each61919-287fbe98f1e-607e-45ec-a31d-96447c2dbde212019-09-05
61919-287-60EA - Each61919-287ee4d1c36-a4dd-441e-bc81-59a1ec49f1f512021-11-09
61919-287-82EA - Each61919-287416106d5-c737-42df-8d23-58cd41aae95c12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-287GLIPIZIDE TABLET [DIRECT_RX]4Legacy NDC, 2 package rows20211020_90922abb-b971-b0dc-e053-2995a90a4efc.zip
61919-287GLIPIZIDE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20210108_48f7b22c-e21e-215c-e054-00144ff8d46c.zip
61919-287GLIPIZIDE TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20210108_90924340-0ad3-0d21-e053-2995a90acd3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310488glipiZIDE 10 MG Oral TabletPSN90922abb-b971-b0dc-e053-2995a90a4efc4
310488glipizide 10 MG Oral TabletSCD90922abb-b971-b0dc-e053-2995a90a4efc4
310488glipiZIDE 10 MG Oral TabletPSN48f7b22c-e21e-215c-e054-00144ff8d46c2
310488glipiZIDE 10 MG Oral TabletPSN90924340-0ad3-0d21-e053-2995a90acd3e2
310488glipizide 10 MG Oral TabletSCD48f7b22c-e21e-215c-e054-00144ff8d46c2
310488glipizide 10 MG Oral TabletSCD90924340-0ad3-0d21-e053-2995a90acd3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-287-306191902873030 TABLET in 1 BOTTLE (61919-287-30) 30 tablet2019-08-200000-00-00NoNoCurrent
61919-287-606191902876060 TABLET in 1 BOTTLE (61919-287-60) 60 tablet2019-08-200000-00-00NoNoCurrent
61919-287-8261919028782180 TABLET in 1 BOTTLE (61919-287-82) 180 tablet2019-08-200000-00-00NoNoCurrent
61919-287-906191902879090 TABLET in 1 BOTTLE (61919-287-90) 90 tablet2017-02-200000-00-00NoNoCurrent