FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-7246
11-digit product format
500907246
Labeler code
50090
Product ID
50090-7246_37dbcdd9-f379-4ce1-9ffb-9e8706bbb674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202112
Marketing category
ANDA
Marketing start
2023-07-31
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
50090-7246-0Glimepiride30 in 1 BOTTLETABLET303
50090-7246-1Glimepiride100 in 1 BOTTLETABLET1003
50090-7246-3Glimepiride90 in 1 BOTTLETABLET903
50090-7246-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7246-0EA - Each50090-7246f5a0f66f-7bf2-4f17-bb3d-dcb5138d95d312024-10-04
50090-7246-1EA - Each50090-72464c79dc25-e28b-4eff-8154-69a42dd658db12024-10-04
50090-7246-3EA - Each50090-7246806df4c6-e33c-4321-86cd-f6bfbe934c4e12024-10-04
50090-7246-4EA - Each50090-724642fae6c9-fd0c-4f91-850f-0e3075fb194a12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7246GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 4 package rows20240919_1e5d562e-b3bf-4502-adc8-c89c8818a9bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSN1e5d562e-b3bf-4502-adc8-c89c8818a9bc3
199246glimepiride 2 MG Oral TabletSCD1e5d562e-b3bf-4502-adc8-c89c8818a9bc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7246-05009072460030 TABLET in 1 BOTTLE (50090-7246-0) 30 tablet2024-09-17NoNoCurrent
50090-7246-150090724601100 TABLET in 1 BOTTLE (50090-7246-1) 100 tablet2024-09-17NoNoCurrent
50090-7246-35009072460390 TABLET in 1 BOTTLE (50090-7246-3) 90 tablet2024-09-17NoNoCurrent
50090-7246-450090724604180 TABLET in 1 BOTTLE (50090-7246-4) 180 tablet2024-09-17NoNoCurrent