Glimepiride

Product NDC
50090-7187
11-digit product format
500907187
Labeler code
50090
Product ID
50090-7187_b18bab5f-8b2c-4685-8c0e-aa6486d67a08
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
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
50090-7187-0Glimepiride30 in 1 BOTTLETABLET304
50090-7187-1Glimepiride100 in 1 BOTTLETABLET1004
50090-7187-2Glimepiride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7187-0EA - Each50090-71871f3617ed-d3bf-48c1-952d-94238aee0e8612024-08-12
50090-7187-1EA - Each50090-7187229906ff-24a3-4555-90fb-74c55ca5ae9712024-08-12
50090-7187-2EA - Each50090-7187e27489f7-fcc0-467b-b7c2-a6e0c5aa1b8112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7187GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]4Current NDC, 3 package rows20250511_49bf2d48-efa8-487b-b861-0124c3a4c951.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN49bf2d48-efa8-487b-b861-0124c3a4c9514
199245glimepiride 1 MG Oral TabletSCD49bf2d48-efa8-487b-b861-0124c3a4c9514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7187-05009071870030 TABLET in 1 BOTTLE (50090-7187-0) 30 tablet2024-07-01NoNoCurrent
50090-7187-150090718701100 TABLET in 1 BOTTLE (50090-7187-1) 100 tablet2024-07-01NoNoCurrent
50090-7187-25009071870290 TABLET in 1 BOTTLE (50090-7187-2) 90 tablet2024-07-01NoNoCurrent