FDA.reportPublic FDA data

Glimepiride

Product NDC
82804-065
11-digit product format
828040065
Labeler code
82804
Product ID
82804-065_0d3fb7c5-9181-4dd7-9724-e26d99d57bbf
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
2 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
GLIMEPIRIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199246

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
82804-065-30Glimepiride30 in 1 BOTTLETABLET302
82804-065-60Glimepiride60 in 1 BOTTLETABLET602
82804-065-78Glimepiride180 in 1 BOTTLETABLET1802
82804-065-90Glimepiride90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-065GLIMEPIRIDE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20240206_dbed06f9-7758-4c96-9af0-1ed6103db7df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNdbed06f9-7758-4c96-9af0-1ed6103db7df2
199246glimepiride 2 MG Oral TabletSCDdbed06f9-7758-4c96-9af0-1ed6103db7df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-065-308280400653030 TABLET in 1 BOTTLE (82804-065-30) 30 tablet2024-01-31NoNoCurrent
82804-065-608280400656060 TABLET in 1 BOTTLE (82804-065-60) 60 tablet2024-01-31NoNoCurrent
82804-065-7882804006578180 TABLET in 1 BOTTLE (82804-065-78) 180 tablet2026-02-18NoNoCurrent
82804-065-908280400659090 TABLET in 1 BOTTLE (82804-065-90) 90 tablet2024-01-31NoNoCurrent