FDA.reportPublic FDA data

Glimepiride

Product NDC
43547-396
11-digit product format
435470396
Labeler code
43547
Product ID
43547-396_95a5568d-751c-4497-b70c-5cc358bbb2af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA077370
Marketing category
ANDA
Marketing start
2017-01-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43547-396-102020-02-25C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-396-502020-02-25C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-396-102020-01-31C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995
43547-396-502020-01-31C16284748780-19d75b9d0-54fd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use glimepiride tablets USP safely and effectively. See full prescribing information for glimepiride tablets USP. Glimepiride Tablets USP, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43547-396-10Glimepiride100 in 1 BOTTLE, PLASTICTABLET1004
43547-396-50Glimepiride500 in 1 BOTTLE, PLASTICTABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-396-10EA - Each43547-39674a2b5f0-cc58-45b8-9ca1-a6663370b4e212017-05-03
43547-396-50EA - Each43547-39686e693cd-7e3e-4ced-b926-dd595b2e1d6012017-05-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-396GLIMEPIRIDE TABLET [SOLCO HEALTHCARE U.S., LLC]4Current NDC, Legacy NDC, 2 package rows20200824_86acdd9e-8637-43e4-8bf7-b3a123b871b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199245glimepiride 1 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199246glimepiride 2 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199247glimepiride 4 MG Oral TabletPSN86acdd9e-8637-43e4-8bf7-b3a123b871b84
199245glimepiride 1 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84
199246glimepiride 2 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84
199247glimepiride 4 MG Oral TabletSCD86acdd9e-8637-43e4-8bf7-b3a123b871b84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-396-1043547039610100 TABLET in 1 BOTTLE, PLASTIC (43547-396-10) 100 tablet2017-01-300000-00-00NoNoCurrent
43547-396-5043547039650500 TABLET in 1 BOTTLE, PLASTIC (43547-396-50) 500 tablet2017-01-300000-00-00NoNoCurrent