FDA.reportPublic FDA data

Glimepiride

Product NDC
50090-6322
11-digit product format
500906322
Labeler code
50090
Product ID
50090-6322_f6d891ed-a372-4f20-b4d3-a77f3af53d71
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
4 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
GLIMEPIRIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199247

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
50090-6322-0Glimepiride30 in 1 BOTTLETABLET303
50090-6322-1Glimepiride100 in 1 BOTTLETABLET1003
50090-6322-2Glimepiride60 in 1 BOTTLETABLET603
50090-6322-3Glimepiride90 in 1 BOTTLETABLET903
50090-6322-4Glimepiride180 in 1 BOTTLETABLET1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6322-0EA - Each50090-6322d8776c79-017f-4a41-a2ee-f77cb15fb1b812023-02-06
50090-6322-1EA - Each50090-632225485073-8362-4bda-953e-f01955ea6ea612023-02-06
50090-6322-2EA - Each50090-63227959c83d-25d7-473d-ad9c-0a4b56b04c5312023-02-06
50090-6322-3EA - Each50090-63228176d336-f527-43a5-ada5-8db5c386b9c912023-02-06
50090-6322-4EA - Each50090-632214490013-f258-4fff-98a7-85dc565bb7aa12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6322GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 5 package rows20230907_a11680ba-2750-43ab-a1b1-a52ebe3e139f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSNa11680ba-2750-43ab-a1b1-a52ebe3e139f3
199247glimepiride 4 MG Oral TabletSCDa11680ba-2750-43ab-a1b1-a52ebe3e139f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6322-05009063220030 TABLET in 1 BOTTLE (50090-6322-0) 30 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-150090632201100 TABLET in 1 BOTTLE (50090-6322-1) 100 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-25009063220260 TABLET in 1 BOTTLE (50090-6322-2) 60 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-35009063220390 TABLET in 1 BOTTLE (50090-6322-3) 90 tablet2023-01-100000-00-00NoNoCurrent
50090-6322-450090632204180 TABLET in 1 BOTTLE (50090-6322-4) 180 tablet2023-01-100000-00-00NoNoCurrent