FDA.reportPublic FDA data

Glimepiride

Product NDC
71205-773
11-digit product format
712050773
Labeler code
71205
Product ID
71205-773_8f687fa6-54eb-4556-8ea6-aafec49a87d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202759
Marketing category
ANDA
Marketing start
2012-06-29
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
71205-773-30Glimepiride30 in 1 BOTTLETABLET301
71205-773-60Glimepiride60 in 1 BOTTLETABLET601
71205-773-78Glimepiride180 in 1 BOTTLETABLET1801
71205-773-90Glimepiride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-773-30EA - Each71205-773e6275c18-84d8-4377-a9b6-b14a400c326812025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-773GLIMEPIRIDE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20230318_8f687fa6-54eb-4556-8ea6-aafec49a87d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199247glimepiride 4 MG Oral TabletPSN8f687fa6-54eb-4556-8ea6-aafec49a87d11
199247glimepiride 4 MG Oral TabletSCD8f687fa6-54eb-4556-8ea6-aafec49a87d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-773-307120507733030 TABLET in 1 BOTTLE (71205-773-30) 30 tablet2023-03-13NoNoCurrent
71205-773-607120507736060 TABLET in 1 BOTTLE (71205-773-60) 60 tablet2023-03-13NoNoCurrent
71205-773-7871205077378180 TABLET in 1 BOTTLE (71205-773-78) 180 tablet2023-03-13NoNoCurrent
71205-773-907120507739090 TABLET in 1 BOTTLE (71205-773-90) 90 tablet2023-03-13NoNoCurrent