FDA.reportPublic FDA data

Glimepiride

Product NDC
68788-8432
11-digit product format
687888432
Labeler code
68788
Product ID
68788-8432_3da4957f-9f52-48f4-8182-1d9a6c292358
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202759
Marketing category
ANDA
Marketing start
2023-04-27
Substance
GLIMEPIRIDE
Active strength
4 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glimepiride
Listing expiration
2027-12-31

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
68788-8432-3Glimepiride30 in 1 BOTTLETABLET304
68788-8432-6Glimepiride60 in 1 BOTTLETABLET604
68788-8432-9Glimepiride90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8432-3EA - Each68788-843215ea476c-424d-4989-88a4-dacef08ce28612023-06-06
68788-8432-6EA - Each68788-8432a8b49520-88f3-4717-a437-ac1a7d4d52d312023-06-06
68788-8432-9EA - Each68788-84328cd786d8-e9f2-4cd4-bee5-8310e8a3ab9312023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8432GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20240511_744a5cca-7863-491a-b43a-1b649791702c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN744a5cca-7863-491a-b43a-1b649791702c4
199247glimepiride 4 MG Oral TabletSCD744a5cca-7863-491a-b43a-1b649791702c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8432-36878884320330 TABLET in 1 BOTTLE (68788-8432-3) 30 tablet2023-04-27NoNoHistorical
68788-8432-66878884320660 TABLET in 1 BOTTLE (68788-8432-6) 60 tablet2023-04-27NoNoHistorical
68788-8432-96878884320990 TABLET in 1 BOTTLE (68788-8432-9) 90 tablet2023-04-27NoNoHistorical