Glyburide

Product NDC
0093-8343
11-digit product format
000938343
Labeler code
0093
Product ID
0093-8343_f4b5b433-1b6e-4af2-9d16-7194c2da041c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
Substance
GLYBURIDE
Active strength
2.5 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
Glyburide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC
Rxcui197737, 310534, 310537

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6Product name220160609
5a2baaae-1290-c05e-207f-b1367e9eb46aProduct name220151005
b044018d-bcdc-e68d-63da-1ad6886aea64Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-8343-01Glyburide100 in 1 BOTTLETABLET10018
0093-8343-05Glyburide500 in 1 BOTTLETABLET50018
0093-8343-10Glyburide1000 in 1 BOTTLETABLET100018
0093-8343-98Glyburide90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8343-01EA - Each0093-834332eead26-cfae-4569-845d-48de95fcb5e112012-07-24
0093-8343-05EA - Each0093-83434e60e80d-a3d0-4775-8b6b-d7be0dd6d17412012-07-24
0093-8343-10EA - Each0093-83433f9adfab-de0a-4099-a17e-c8c59d4d63aa12012-07-24
0093-8343-98EA - Each0093-834341b3afec-44a4-48ef-9d6c-bc578a07295f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8343GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 4 package rows20211030_a56f100f-0f42-4188-81ab-04644b824040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSNa56f100f-0f42-4188-81ab-04644b82404018
310534glyBURIDE 2.5 MG Oral TabletPSNa56f100f-0f42-4188-81ab-04644b82404018
310537glyBURIDE 5 MG Oral TabletPSNa56f100f-0f42-4188-81ab-04644b82404018
197737glyburide 1.25 MG Oral TabletSCDa56f100f-0f42-4188-81ab-04644b82404018
310534glyburide 2.5 MG Oral TabletSCDa56f100f-0f42-4188-81ab-04644b82404018
310537glyburide 5 MG Oral TabletSCDa56f100f-0f42-4188-81ab-04644b82404018
197737glibenclamide 1.25 MG Oral TabletSYa56f100f-0f42-4188-81ab-04644b82404018
310534glibenclamide 2.5 MG Oral TabletSYa56f100f-0f42-4188-81ab-04644b82404018
310537glibenclamide 5 MG Oral TabletSYa56f100f-0f42-4188-81ab-04644b82404018
310534glyBURIDE 2.5 MG Oral TabletPSN64a1ee72-cbe4-4558-899c-825c4b6d943511
310534glyburide 2.5 MG Oral TabletSCD64a1ee72-cbe4-4558-899c-825c4b6d943511
310534glibenclamide 2.5 MG Oral TabletSY64a1ee72-cbe4-4558-899c-825c4b6d943511
310534glyBURIDE 2.5 MG Oral TabletPSN4b6b2ce1-e349-3921-e054-00144ff8d46c4
310534glyburide 2.5 MG Oral TabletSCD4b6b2ce1-e349-3921-e054-00144ff8d46c4
310534glibenclamide 2.5 MG Oral TabletSY4b6b2ce1-e349-3921-e054-00144ff8d46c4
310534glyBURIDE 2.5 MG Oral TabletPSNec45f0d8-cab8-4822-895b-17bb443a4f983
310534glyburide 2.5 MG Oral TabletSCDec45f0d8-cab8-4822-895b-17bb443a4f983
310534glibenclamide 2.5 MG Oral TabletSYec45f0d8-cab8-4822-895b-17bb443a4f983
310534glyBURIDE 2.5 MG Oral TabletPSN4573af7f-3c71-e323-e063-6394a90aa9eb1
310534glyburide 2.5 MG Oral TabletSCD4573af7f-3c71-e323-e063-6394a90aa9eb1
310534glibenclamide 2.5 MG Oral TabletSY4573af7f-3c71-e323-e063-6394a90aa9eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8343-0100093834301100 TABLET in 1 BOTTLE (0093-8343-01) 100 tablet1995-08-300000-00-00NoNoCurrent
0093-8343-0500093834305500 TABLET in 1 BOTTLE (0093-8343-05) 500 tablet1995-08-300000-00-00NoNoCurrent
0093-8343-10000938343101000 TABLET in 1 BOTTLE (0093-8343-10) 1000 tablet1995-08-300000-00-00NoNoCurrent
0093-8343-980009383439890 TABLET in 1 BOTTLE (0093-8343-98) 90 tablet2010-03-300000-00-00NoNoCurrent