FDA.reportPublic FDA data

Glimepiride

Product NDC
70934-323
11-digit product format
709340323
Labeler code
70934
Product ID
70934-323_b7b1907c-9120-8dcb-e053-2995a90a57eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA078181
Marketing category
ANDA
Marketing start
2019-03-20
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
70934-323-302023-01-30C16284748780-1f386c64a-1633-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral use Initial U.S. Approval: 1995
70934-323-902023-01-30C16284748780-1f386c64a-1633-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GLIMEPIRIDE TABLETS safely and effectively. See full prescribing information for GLIMEPIRIDE TABLETS. GLIMEPIRIDE tablets for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-323-30Glimepiride30 in 1 BOTTLE, PLASTICTABLET302
70934-323-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-323-30EA - Each70934-323cf7750c9-21d0-4a9a-940a-5a77e40386f912022-12-07
70934-323-90EA - Each70934-323e7748530-45f3-48a2-ad60-6913115870d912021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-323GLIMEPIRIDE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20201231_8aaa0f8d-754f-059a-e053-2995a90a0e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN8aaa0f8d-754f-059a-e053-2995a90a0e7f2
199247glimepiride 4 MG Oral TabletSCD8aaa0f8d-754f-059a-e053-2995a90a0e7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-323-307093403233030 TABLET in 1 BOTTLE, PLASTIC (70934-323-30) 30 tablet2019-03-200000-00-00NoNoCurrent
70934-323-907093403239090 TABLET in 1 BOTTLE, PLASTIC (70934-323-90) 90 tablet2019-06-050000-00-00NoNoCurrent