FDA.reportPublic FDA data

Glimepiride

Product NDC
68788-8728
11-digit product format
687888728
Labeler code
68788
Product ID
68788-8728_31dedbcc-cef1-4d2f-adba-0738761d2300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202112
Marketing category
ANDA
Marketing start
2024-08-19
Substance
GLIMEPIRIDE
Active strength
2 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
GLIMEPIRIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui199246

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
68788-8728-1Glimepiride100 in 1 BOTTLETABLET1003
68788-8728-3Glimepiride30 in 1 BOTTLETABLET303
68788-8728-6Glimepiride60 in 1 BOTTLETABLET603
68788-8728-9Glimepiride90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8728-1EA - Each68788-87280d114b83-466b-4c31-aa45-ecf4e64a1b2712024-10-04
68788-8728-3EA - Each68788-87287bc7d0bf-1345-42f5-8948-5f141ffa31b412024-10-04
68788-8728-6EA - Each68788-87280d0c1f07-190f-443b-a1b4-7f9c5398697912024-10-04
68788-8728-9EA - Each68788-8728a5cb6f40-6842-407a-8da7-6c61eff390e412024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8728GLIMEPIRIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240820_f69e36b9-4940-4f01-b5ea-59dc66dc1e87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNf69e36b9-4940-4f01-b5ea-59dc66dc1e873
199246glimepiride 2 MG Oral TabletSCDf69e36b9-4940-4f01-b5ea-59dc66dc1e873

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8728-168788872801100 TABLET in 1 BOTTLE (68788-8728-1) 100 tablet2024-08-19NoNoHistorical
68788-8728-36878887280330 TABLET in 1 BOTTLE (68788-8728-3) 30 tablet2024-08-19NoNoHistorical
68788-8728-66878887280660 TABLET in 1 BOTTLE (68788-8728-6) 60 tablet2024-08-19NoNoHistorical
68788-8728-96878887280990 TABLET in 1 BOTTLE (68788-8728-9) 90 tablet2024-08-19NoNoHistorical