FDA.reportPublic FDA data

Glimepiride

Product NDC
71205-779
11-digit product format
712050779
Labeler code
71205
Product ID
71205-779_96861cce-7d27-4c47-8410-7d19572f5fcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
71205-779-30Glimepiride30 in 1 BOTTLETABLET302
71205-779-60Glimepiride60 in 1 BOTTLETABLET602
71205-779-78Glimepiride180 in 1 BOTTLETABLET1802
71205-779-90Glimepiride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-779-90EA - Each71205-779ec5c6e56-b710-4365-8a5f-29edf161fc3d12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-779GLIMEPIRIDE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20230407_e12ab052-e3d6-4246-b727-f1e3f9057f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNe12ab052-e3d6-4246-b727-f1e3f9057f092
199245glimepiride 1 MG Oral TabletSCDe12ab052-e3d6-4246-b727-f1e3f9057f092

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-779-307120507793030 TABLET in 1 BOTTLE (71205-779-30) 30 tablet2023-03-23NoNoHistorical
71205-779-607120507796060 TABLET in 1 BOTTLE (71205-779-60) 60 tablet2023-03-23NoNoHistorical
71205-779-7871205077978180 TABLET in 1 BOTTLE (71205-779-78) 180 tablet2026-02-25NoNoHistorical
71205-779-907120507799090 TABLET in 1 BOTTLE (71205-779-90) 90 tablet2023-03-23NoNoHistorical