FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-6426
11-digit product format
500906426
Labeler code
50090
Product ID
50090-6426_4de04665-3a18-487c-9232-7c1362e3a316
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
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
50090-6426-0Glimepiride30 in 1 BOTTLETABLET303
50090-6426-1Glimepiride100 in 1 BOTTLETABLET1003
50090-6426-3Glimepiride90 in 1 BOTTLETABLET903
50090-6426-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6426-0EA - Each50090-6426716a9179-0567-48ee-8841-8c8e0f92f3e312023-06-06
50090-6426-1EA - Each50090-6426bbf7791c-c98c-4471-bbeb-0633a2d251b512023-06-06
50090-6426-3EA - Each50090-6426c5c67ed1-83be-42f0-921b-559574fe0b6912023-06-06
50090-6426-4EA - Each50090-642690fe943e-5554-4399-bfbd-3c1cca979c4c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6426GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 4 package rows20230421_489dc098-0ac7-4f8e-b258-326229539c7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN489dc098-0ac7-4f8e-b258-326229539c7c3
199246glimepiride 2 MG Oral TabletSCD489dc098-0ac7-4f8e-b258-326229539c7c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6426-05009064260030 TABLET in 1 BOTTLE (50090-6426-0) 30 tablet2023-04-07NoNoCurrent
50090-6426-150090642601100 TABLET in 1 BOTTLE (50090-6426-1) 100 tablet2023-04-07NoNoCurrent
50090-6426-35009064260390 TABLET in 1 BOTTLE (50090-6426-3) 90 tablet2023-04-07NoNoCurrent
50090-6426-450090642604180 TABLET in 1 BOTTLE (50090-6426-4) 180 tablet2023-04-07NoNoCurrent