FDA.reportPublic FDA data

Glyburide

Product NDC
0093-8344
11-digit product format
000938344
Labeler code
0093
Product ID
0093-8344_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
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
GLYBURIDE5 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
0093-8344-01Glyburide100 in 1 BOTTLETABLET10018
0093-8344-05Glyburide500 in 1 BOTTLETABLET50018
0093-8344-10Glyburide1000 in 1 BOTTLETABLET100018
0093-8344-98Glyburide90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-8344-01EA - Each0093-83446ea2b270-d4e0-4ebc-8cee-e0b845621e8512012-07-24
0093-8344-05EA - Each0093-8344e6e85345-d0ec-4b13-a1af-6ce84e9eef5312012-07-24
0093-8344-10EA - Each0093-83442622bf1d-bdb8-406a-811f-c6759656705c12012-07-24
0093-8344-19EA - Each0093-8344ef93c958-3e1e-4192-a378-f13d90ec07d012012-07-24
0093-8344-93EA - Each0093-8344309e3e7a-08a2-4fea-bc1e-f6d47fc6fec712012-07-24
0093-8344-98EA - Each0093-8344e5f78c6c-a59e-4731-8e27-e112e1d278d112012-07-24

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
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [MEDVANTX, INC.]1
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [MEDVANTX, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE TABLET [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-8344GLYBURIDE 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
310537glyBURIDE 5 MG Oral TabletPSN387dd732-a638-4b4b-b3d3-ee2c541923de5
310537glyburide 5 MG Oral TabletSCD387dd732-a638-4b4b-b3d3-ee2c541923de5
310537glibenclamide 5 MG Oral TabletSY387dd732-a638-4b4b-b3d3-ee2c541923de5
310537glyBURIDE 5 MG Oral TabletPSN6f65131c-90df-45ab-95fb-c36f411c6fbe2
310537glyburide 5 MG Oral TabletSCD6f65131c-90df-45ab-95fb-c36f411c6fbe2
310537glibenclamide 5 MG Oral TabletSY6f65131c-90df-45ab-95fb-c36f411c6fbe2
310537glyBURIDE 5 MG Oral TabletPSN922d1080-52c6-41e4-a310-533d8ca185941
310537glyBURIDE 5 MG Oral TabletPSNa53e29b3-7436-419f-ad6c-0a805d97ab1a1
310537glyBURIDE 5 MG Oral TabletPSNbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1
310537glyBURIDE 5 MG Oral TabletPSN25516c2a-f1b5-9ee4-e063-6394a90ab46b1
310537glyBURIDE 5 MG Oral TabletPSN21786ac0-da3c-16cb-e063-6394a90a45961
310537glyburide 5 MG Oral TabletSCDa53e29b3-7436-419f-ad6c-0a805d97ab1a1
310537glyburide 5 MG Oral TabletSCD21786ac0-da3c-16cb-e063-6394a90a45961
310537glyburide 5 MG Oral TabletSCD922d1080-52c6-41e4-a310-533d8ca185941
310537glyburide 5 MG Oral TabletSCD25516c2a-f1b5-9ee4-e063-6394a90ab46b1
310537glyburide 5 MG Oral TabletSCDbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1
310537glibenclamide 5 MG Oral TabletSYa53e29b3-7436-419f-ad6c-0a805d97ab1a1
310537glibenclamide 5 MG Oral TabletSYbc8df889-25e0-49a0-bbec-a3dfae8bbb8a1
310537glibenclamide 5 MG Oral TabletSY922d1080-52c6-41e4-a310-533d8ca185941
310537glibenclamide 5 MG Oral TabletSY25516c2a-f1b5-9ee4-e063-6394a90ab46b1
310537glibenclamide 5 MG Oral TabletSY21786ac0-da3c-16cb-e063-6394a90a45961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-8344-0100093834401100 TABLET in 1 BOTTLE (0093-8344-01) 100 tablet1995-08-300000-00-00NoNoCurrent
0093-8344-0500093834405500 TABLET in 1 BOTTLE (0093-8344-05) 500 tablet1995-08-300000-00-00NoNoCurrent
0093-8344-10000938344101000 TABLET in 1 BOTTLE (0093-8344-10) 1000 tablet1995-08-300000-00-00NoNoCurrent
0093-8344-980009383449890 TABLET in 1 BOTTLE (0093-8344-98) 90 tablet2010-03-300000-00-00NoNoCurrent