FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-6394
11-digit product format
500906394
Labeler code
50090
Product ID
50090-6394_ec154992-07c0-4760-b39f-b7eb04abe8ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
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
50090-6394-0Glimepiride30 in 1 BOTTLETABLET308
50090-6394-1Glimepiride100 in 1 BOTTLETABLET1008
50090-6394-2Glimepiride90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6394-0EA - Each50090-6394b2137e86-d183-47f3-a64d-d1d4317714fe12023-04-07
50090-6394-1EA - Each50090-6394d32822b1-86f6-4aa3-8c46-39dbfe309d3612023-06-06
50090-6394-2EA - Each50090-639468ad2b18-5700-4dc4-8d71-5517ef3adcb812023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6394GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, 3 package rows20230901_e8da2484-43a7-4dcb-84d5-d84596feb9f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSNe8da2484-43a7-4dcb-84d5-d84596feb9f68
199245glimepiride 1 MG Oral TabletSCDe8da2484-43a7-4dcb-84d5-d84596feb9f68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6394-05009063940030 TABLET in 1 BOTTLE (50090-6394-0) 30 tablet2023-03-13NoNoHistorical
50090-6394-150090639401100 TABLET in 1 BOTTLE (50090-6394-1) 100 tablet2023-03-20NoNoHistorical
50090-6394-25009063940290 TABLET in 1 BOTTLE (50090-6394-2) 90 tablet2023-04-28NoNoHistorical