Glimepiride

Product NDC
50090-3547
11-digit product format
500903547
Labeler code
50090
Product ID
50090-3547_726ca015-92e9-457a-ad1b-012fc4e65ede
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078181
Marketing category
ANDA
Marketing start
2007-08-23
Marketing end
0000-00-00
Substance
GLIMEPIRIDE
Active strength
1 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3547-0Glimepiride30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3547-0EA - Each50090-3547fe06b295-a48d-4a55-b2e2-a58b7ada551712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3547GLIMEPIRIDE TABLET [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20180824_2b7f8d5f-ae07-4706-ac99-89e26c11321f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN2b7f8d5f-ae07-4706-ac99-89e26c11321f2
199245glimepiride 1 MG Oral TabletSCD2b7f8d5f-ae07-4706-ac99-89e26c11321f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3547-05009035470030 in 1 BOTTLEHistorical