Glimepiride

Product NDC
71335-1885
11-digit product format
713351885
Labeler code
71335
Product ID
71335-1885_c67f1d41-3dc2-405d-916a-b386b30cbe55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091220
Marketing category
ANDA
Marketing start
2013-06-13
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2026-12-31

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
71335-1885-1Glimepiride30 in 1 BOTTLETABLET30104
71335-1885-2Glimepiride60 in 1 BOTTLETABLET60104
71335-1885-3Glimepiride90 in 1 BOTTLETABLET90104
71335-1885-4Glimepiride100 in 1 BOTTLETABLET100104
71335-1885-5Glimepiride20 in 1 BOTTLETABLET20104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1885GLIMEPIRIDE (GLIMEPIRIDE) TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20240524_d4513181-4558-4d9a-851b-acf7e3eda25a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNd4513181-4558-4d9a-851b-acf7e3eda25a104
199245glimepiride 1 MG Oral TabletSCDd4513181-4558-4d9a-851b-acf7e3eda25a104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1885-17133518850130 TABLET in 1 BOTTLE (71335-1885-1) 30 tablet2021-11-090000-00-00NoNoCurrent
71335-1885-27133518850260 TABLET in 1 BOTTLE (71335-1885-2) 60 tablet2025-06-160000-00-00NoNoCurrent
71335-1885-37133518850390 TABLET in 1 BOTTLE (71335-1885-3) 90 tablet2021-05-280000-00-00NoNoCurrent
71335-1885-471335188504100 TABLET in 1 BOTTLE (71335-1885-4) 100 tablet2025-06-160000-00-00NoNoCurrent
71335-1885-57133518850520 TABLET in 1 BOTTLE (71335-1885-5) 20 tablet2025-06-160000-00-00NoNoCurrent