Glimepiride 3 mg

Product NDC
72336-641
11-digit product format
723360641
Labeler code
72336
Product ID
72336-641_8f56950f-d08d-44d4-9c7c-9830e9bfadb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Lifsa Drugs LLC
Application
ANDA091220
Marketing category
ANDA
Marketing start
2024-08-20
Substance
GLIMEPIRIDE
Active strength
3 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 3 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIMEPIRIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6KY687524K
Rxcui153842

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
72336-641-01Glimepiride 3 mg100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72336-641-01EA - Each72336-641a62b97ce-25c7-4cb6-ae08-28277576263f12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72336-641GLIMEPIRIDE 3 MG (GLIMEPIRIDE) TABLET [LIFSA DRUGS LLC]1Current NDC, 1 package rows20240824_51157849-7990-4a8b-ae50-eda1baf93cfa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153842glimepiride 3 MG Oral TabletPSN51157849-7990-4a8b-ae50-eda1baf93cfa1
153842glimepiride 3 MG Oral TabletSCD51157849-7990-4a8b-ae50-eda1baf93cfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72336-641-0172336064101100 TABLET in 1 BOTTLE (72336-641-01) 100 tablet2024-08-20NoNoCurrent