FDA.reportPublic FDA data

Glimepiride

Product NDC
63629-3043
11-digit product format
636293043
Labeler code
63629
Product ID
63629-3043_d877f389-167f-42c4-a9c2-adc90a7cad20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glimepiride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077091
Marketing category
ANDA
Marketing start
2005-10-06
Substance
GLIMEPIRIDE
Active strength
2 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
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
63629-3043-1Glimepiride30 in 1 BOTTLETABLET308
63629-3043-2Glimepiride60 in 1 BOTTLETABLET608
63629-3043-3Glimepiride90 in 1 BOTTLETABLET908
63629-3043-4Glimepiride100 in 1 BOTTLETABLET1008
63629-3043-5Glimepiride180 in 1 BOTTLETABLET1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3043-1EA - Each63629-3043744a3d19-6a05-4d31-be3f-5ab0bc447ee112012-07-24
63629-3043-2EA - Each63629-3043c2fa4a4d-1a91-49cf-81b3-842fc0c83cb812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIMEPIRIDEACTIVE INGREDIENT6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
GLIMEPIRIDEACTIVE MOIETY6KY687524KGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EGLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3043GLIMEPIRIDE TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20200828_ebb9f080-b11d-5d18-36f0-627107e7fbcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199246glimepiride 2 MG Oral TabletPSNebb9f080-b11d-5d18-36f0-627107e7fbcd8
199246glimepiride 2 MG Oral TabletSCDebb9f080-b11d-5d18-36f0-627107e7fbcd8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3043-16362930430130 TABLET in 1 BOTTLE (63629-3043-1) 30 tablet2010-06-230000-00-00NoNoCurrent
63629-3043-26362930430260 TABLET in 1 BOTTLE (63629-3043-2) 60 tablet2010-06-230000-00-00NoNoCurrent
63629-3043-36362930430390 TABLET in 1 BOTTLE (63629-3043-3) 90 tablet2007-06-070000-00-00NoNoCurrent
63629-3043-463629304304100 TABLET in 1 BOTTLE (63629-3043-4) 100 tablet2007-06-070000-00-00NoNoCurrent
63629-3043-563629304305180 TABLET in 1 BOTTLE (63629-3043-5) 180 tablet2010-06-230000-00-00NoNoCurrent