FDA.reportPublic FDA data

Glimepiride

Product NDC
71335-9654
11-digit product format
713359654
Labeler code
71335
Product ID
71335-9654_d2711080-78c7-4f35-8b7d-a8b499c0d13f
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
4 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
GLIMEPIRIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199247

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
71335-9654-1Glimepiride30 in 1 BOTTLETABLET30105
71335-9654-2Glimepiride60 in 1 BOTTLETABLET60105
71335-9654-3Glimepiride90 in 1 BOTTLETABLET90105
71335-9654-4Glimepiride180 in 1 BOTTLETABLET180105
71335-9654-5Glimepiride100 in 1 BOTTLETABLET100105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9654GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]104Current NDC, 5 package rows20240828_90d675cb-6def-49a3-b8b4-229f19d6b617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN90d675cb-6def-49a3-b8b4-229f19d6b617105
199247glimepiride 4 MG Oral TabletSCD90d675cb-6def-49a3-b8b4-229f19d6b617105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9654-17133596540130 TABLET in 1 BOTTLE (71335-9654-1) 30 tablet2023-03-13NoNoHistorical
71335-9654-27133596540260 TABLET in 1 BOTTLE (71335-9654-2) 60 tablet2023-04-18NoNoHistorical
71335-9654-37133596540390 TABLET in 1 BOTTLE (71335-9654-3) 90 tablet2023-02-21NoNoHistorical
71335-9654-471335965404180 TABLET in 1 BOTTLE (71335-9654-4) 180 tablet2023-05-24NoNoHistorical
71335-9654-571335965405100 TABLET in 1 BOTTLE (71335-9654-5) 100 tablet2023-03-17NoNoHistorical