FDA.reportPublic FDA data

Glimepiride

Product NDC
71335-9655
11-digit product format
713359655
Labeler code
71335
Product ID
71335-9655_b5d233a0-5a73-4eb6-b622-12fa69765006
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202759
Marketing category
ANDA
Marketing start
2012-06-29
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199245

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9655-1Glimepiride30 in 1 BOTTLETABLET30102
71335-9655-2Glimepiride60 in 1 BOTTLETABLET60102
71335-9655-3Glimepiride90 in 1 BOTTLETABLET90102
71335-9655-4Glimepiride100 in 1 BOTTLETABLET100102
71335-9655-5Glimepiride20 in 1 BOTTLETABLET20102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9655GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 5 package rows20231123_248c3cb3-4501-4b85-bd1d-0624b6afda2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN248c3cb3-4501-4b85-bd1d-0624b6afda2c102
199245glimepiride 1 MG Oral TabletSCD248c3cb3-4501-4b85-bd1d-0624b6afda2c102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9655-17133596550130 TABLET in 1 BOTTLE (71335-9655-1) 30 tablet2023-03-28NoNoHistorical
71335-9655-27133596550260 TABLET in 1 BOTTLE (71335-9655-2) 60 tablet2026-04-13NoNoHistorical
71335-9655-37133596550390 TABLET in 1 BOTTLE (71335-9655-3) 90 tablet2023-03-10NoNoHistorical
71335-9655-471335965504100 TABLET in 1 BOTTLE (71335-9655-4) 100 tablet2023-03-17NoNoHistorical
71335-9655-57133596550520 TABLET in 1 BOTTLE (71335-9655-5) 20 tablet2026-04-13NoNoHistorical