FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-6415
11-digit product format
500906415
Labeler code
50090
Product ID
50090-6415_91f7fd75-daf4-4966-8bcb-459ebe412a36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
2 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
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
50090-6415-0Glimepiride30 in 1 BOTTLETABLET303
50090-6415-1Glimepiride100 in 1 BOTTLETABLET1003
50090-6415-3Glimepiride90 in 1 BOTTLETABLET903
50090-6415-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6415-0EA - Each50090-6415bdaff7b2-a6a3-48de-bfe2-fb39db3345a912023-05-05
50090-6415-1EA - Each50090-64159910ab74-e367-43f4-95ee-0723a6e4cff312023-05-05
50090-6415-3EA - Each50090-6415e3a07bd5-f29a-48d0-ae23-d561b5d7c53312023-05-05
50090-6415-4EA - Each50090-64150f611bde-744b-48bb-8153-c10a594aab4712023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6415GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 4 package rows20231215_0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b3
199246glimepiride 2 MG Oral TabletSCD0a1eaf23-d5fd-4b3e-96c5-68ff16f0033b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6415-05009064150030 TABLET in 1 BOTTLE (50090-6415-0) 30 tablet2023-03-29NoNoCurrent
50090-6415-150090641501100 TABLET in 1 BOTTLE (50090-6415-1) 100 tablet2023-03-29NoNoCurrent
50090-6415-35009064150390 TABLET in 1 BOTTLE (50090-6415-3) 90 tablet2023-03-29NoNoCurrent
50090-6415-450090641504180 TABLET in 1 BOTTLE (50090-6415-4) 180 tablet2023-03-29NoNoCurrent