Glimepiride

Product NDC
68084-327
11-digit product format
680840327
Labeler code
68084
Product ID
68084-327_26cca05b-82f8-e191-e063-6394a90a56bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077091
Marketing category
ANDA
Marketing start
2009-04-22
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
Rxcui199245, 199246, 199247

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
68084-327-01Glimepiride100 in 1 BOX, UNIT-DOSETABLET10011
68084-327-11Glimepiride1 in 1 BLISTER PACKTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-327-01EA - Each68084-3279f633093-cf20-40fc-8587-dcd9ec9f302612012-07-24
68084-327-11EA - Each68084-327f0658069-09dd-4160-9798-d9d960a8cc7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
ferric oxide redINACTIVE INGREDIENT1K09F3G675GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
magnesium stearateINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-327GLIMEPIRIDE TABLET [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20241122_0003458f-352a-46fa-9d99-230daa76ae29.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletPSN0003458f-352a-46fa-9d99-230daa76ae2911
199245glimepiride 1 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199246glimepiride 2 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911
199247glimepiride 4 MG Oral TabletSCD0003458f-352a-46fa-9d99-230daa76ae2911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-327-0168084032701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11) 100 blister pack2009-04-220000-00-00NoNoCurrent
68084-327-11680840327111 in 1 BLISTER PACKHistorical