Glimepiride

Product NDC
33261-961
11-digit product format
332610961
Labeler code
33261
Product ID
33261-961_990b3277-93c4-4a03-a208-d1a5426546f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077911
Marketing category
ANDA
Marketing start
2017-08-17
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
33261-961-30Glimepiride30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-961-30EA - Each33261-9610d70b7e2-2d0d-475b-aa23-01c0719df4a112018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-961GLIMEPIRIDE TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180531_3d982d65-130b-488d-bffb-36a2e8ac055f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN3d982d65-130b-488d-bffb-36a2e8ac055f1
199245glimepiride 1 MG Oral TabletSCD3d982d65-130b-488d-bffb-36a2e8ac055f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-961-303326109613030 in 1 BOTTLEHistorical