Glyburide

Product NDC
0093-9433
11-digit product format
000939433
Labeler code
0093
Product ID
0093-9433_84b83205-8813-494e-933e-a70697393744
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
TEVA Pharmaceuticals USA Inc
Application
NDA017532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-05-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017532-001DIABETAGLYBURIDE1.25MGTABLET / ORALAB2RLD1984-05-01
N017532-002DIABETAGLYBURIDE2.5MGTABLET / ORALAB2RLD1984-05-01
N017532-003DIABETAGLYBURIDE5MGTABLET / ORALAB2RLD, RS1984-05-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N017532-001AB2
N017532-002AB2
N017532-003AB2

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-018072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017532-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017532-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017532-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017532-001AB218072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SX6K58TVWCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197737Internal RxNorm lookup
310534Internal RxNorm lookup
310537Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50d16f1d-c814-4411-8749-62561321ecceAvailable on FDA.report

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
0093-9433-01Glyburide100 in 1 BOTTLETABLET10013
0093-9433-05Glyburide500 in 1 BOTTLETABLET50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-9433-01EA - Each0093-9433cf50635e-61a7-4d34-83da-ec18d679be7112012-07-24
0093-9433-05EA - Each0093-943305309304-66a4-4660-9790-b1a9650698a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
glyburideACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
glyburideACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
Aluminum OxideINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
magnesium stearateINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
sodium alginateINACTIVE INGREDIENTC269C4G2ZQGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
talcINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]9
glyburideACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
glyburideACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
Aluminum OxideINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
FD&C Blue no. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
magnesium stearateINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
sodium alginateINACTIVE INGREDIENTC269C4G2ZQGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
talcINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]7
glyburideACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
glyburideACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
calcium phosphate, dibasic, anhydrousINACTIVE INGREDIENTL11K75P92JGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C Blue no. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOAGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
sodium alginateINACTIVE INGREDIENTC269C4G2ZQGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
talcINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-9433GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]13Current NDC, Legacy NDC, 2 package rows20210829_50d16f1d-c814-4411-8749-62561321ecce.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDETEVA Pharmaceuticals USA Inc50d16f1d-c814-4411-8749-62561321ecce2021-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 017532
application number: NDA017532
ndc (product): 0093-9433

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197737glyBURIDE 1.25 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
310534glyBURIDE 2.5 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
310537glyBURIDE 5 MG Oral TabletPSN50d16f1d-c814-4411-8749-62561321ecce13
197737glyburide 1.25 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
310534glyburide 2.5 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
310537glyburide 5 MG Oral TabletSCD50d16f1d-c814-4411-8749-62561321ecce13
197737glibenclamide 1.25 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
310534glibenclamide 2.5 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
310537glibenclamide 5 MG Oral TabletSY50d16f1d-c814-4411-8749-62561321ecce13
197737glyBURIDE 1.25 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
310534glyBURIDE 2.5 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
310537glyBURIDE 5 MG Oral TabletPSN820400e2-d340-416d-9015-c563577803623
197737glyburide 1.25 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
310534glyburide 2.5 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
310537glyburide 5 MG Oral TabletSCD820400e2-d340-416d-9015-c563577803623
197737glibenclamide 1.25 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623
310534glibenclamide 2.5 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623
310537glibenclamide 5 MG Oral TabletSY820400e2-d340-416d-9015-c563577803623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-9433-0100093943301100 TABLET in 1 BOTTLE (0093-9433-01) 100 tablet1984-05-010000-00-00NoNoCurrent
0093-9433-0500093943305500 TABLET in 1 BOTTLE (0093-9433-05) 500 tablet1984-05-010000-00-00NoNoCurrent