Glimepiride

Product NDC
60760-845
11-digit product format
607600845
Labeler code
60760
Product ID
60760-845_35ba2cc7-d1ab-5e85-e063-6394a90a1cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA202112
Marketing category
ANDA
Marketing start
2023-07-31
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
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
60760-845-90Glimepiride90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-845-90EA - Each60760-84583fc945f-2ac8-471d-980b-016a2d47bfae12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-845GLIMEPIRIDE TABLET [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, 1 package rows20250523_35ba31ef-2b90-61c6-e063-6394a90a59ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN35ba31ef-2b90-61c6-e063-6394a90a59ee1
199247glimepiride 4 MG Oral TabletSCD35ba31ef-2b90-61c6-e063-6394a90a59ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60760-845-906076008459090 TABLET in 1 BOTTLE, PLASTIC (60760-845-90) 90 tablet2025-05-15NoNoHistorical