Glyburide

Product NDC
72241-039
11-digit product format
722410039
Labeler code
72241
Product ID
72241-039_7ebf5b06-fdd3-4120-93f2-d31def5bf104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA203379
Marketing category
ANDA
Marketing start
2021-10-05
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
A203379-001GLYBURIDEGLYBURIDE1.25MGTABLET / ORALAB12019-01-04
A203379-002GLYBURIDEGLYBURIDE2.5MGTABLET / ORALAB12019-01-04
A203379-003GLYBURIDEGLYBURIDE5MGTABLET / ORALAB12019-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203379-001AB1
A203379-002AB1
A203379-003AB1

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 UTC2026-02A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-002GLYBURIDE2.5MGTABLET / ORALAB12019-01-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-003GLYBURIDE5MGTABLET / ORALAB12019-01-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203379-001GLYBURIDE1.25MGTABLET / ORALAB12019-01-048072bd15b7f6…

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 UTC2026-02A203379-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203379-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203379-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203379-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203379-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203379-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203379-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203379-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203379-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203379-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203379-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203379-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203379-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203379-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203379-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203379-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203379-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203379-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203379-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203379-001AB118072bd15b7f6…

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
a5de0ef6-4c8b-40ab-b0ed-2003a8086750Available 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
72241-039-05Glyburide100 in 1 BOTTLETABLET1002
72241-039-10Glyburide500 in 1 BOTTLETABLET5002
72241-039-11Glyburide1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-039-05EA - Each72241-039046b07c3-d72a-4df1-8b86-28dbf4e208dc12022-01-06
72241-039-10EA - Each72241-0391198e4b8-b889-496a-9fa2-5c2ab991333b12022-01-06
72241-039-11EA - Each72241-03904f58264-872d-40ac-8a03-c20e4388272312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-039GLYBURIDE TABLET [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 3 package rows20221230_a5de0ef6-4c8b-40ab-b0ed-2003a8086750.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDEREMEDYREPACK INC.524eec41-37ee-419a-b7a1-d23e888ae6ab2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEREMEDYREPACK INC.e23b9a3b-0184-4d1c-8e2c-668697a6da872026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEPreferred Pharmaceuticals Inc.cf21c8c0-7247-4d5b-97f8-ae40161446422026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEA-S Medication Solutions51cf08e2-8a2f-4bde-996f-f431f1a68abd2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.ffd31d06-6011-34e2-e053-6394a90a437f2026-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEBryant Ranch Prepackdb074991-1267-454a-8b1d-b6f52e2132cc2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEA-S Medication Solutions676c0e45-0aa2-4060-ad18-67abb9873a502024-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEA-S Medication Solutionsd090f978-b1a5-4db7-951d-3f32dd06966c2024-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDECadila Pharmaceuticals Limitedea7a055b-64f0-46bf-aa8e-4a2ef5c3c0352022-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
GlyburideGLYBURIDEModavar Pharmaceuticals LLCa5de0ef6-4c8b-40ab-b0ed-2003a80867502022-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379
ndc (product): 72241-039
GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.43c6f68b-5747-47c6-9538-51ef8c611db42021-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203379
application number: ANDA203379

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310534glyBURIDE 2.5 MG Oral TabletPSNe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glyburide 2.5 MG Oral TabletSCDe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glibenclamide 2.5 MG Oral TabletSYe23b9a3b-0184-4d1c-8e2c-668697a6da878
310534glyBURIDE 2.5 MG Oral TabletPSN676c0e45-0aa2-4060-ad18-67abb9873a505
310534glyburide 2.5 MG Oral TabletSCD676c0e45-0aa2-4060-ad18-67abb9873a505
310534glibenclamide 2.5 MG Oral TabletSY676c0e45-0aa2-4060-ad18-67abb9873a505
197737glyBURIDE 1.25 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyBURIDE 2.5 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glyBURIDE 5 MG Oral TabletPSNa5de0ef6-4c8b-40ab-b0ed-2003a80867502
197737glyburide 1.25 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyburide 2.5 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glyburide 5 MG Oral TabletSCDa5de0ef6-4c8b-40ab-b0ed-2003a80867502
197737glibenclamide 1.25 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glibenclamide 2.5 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310537glibenclamide 5 MG Oral TabletSYa5de0ef6-4c8b-40ab-b0ed-2003a80867502
310534glyBURIDE 2.5 MG Oral TabletPSN26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glyBURIDE 2.5 MG Oral TabletPSN03c1e0ae-6081-f9a6-e063-6294a90a6d871
310534glyburide 2.5 MG Oral TabletSCD03c1e0ae-6081-f9a6-e063-6294a90a6d871
310534glyburide 2.5 MG Oral TabletSCD26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glibenclamide 2.5 MG Oral TabletSY26a39d3f-3f71-31b6-e063-6394a90a7b841
310534glibenclamide 2.5 MG Oral TabletSY03c1e0ae-6081-f9a6-e063-6294a90a6d871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-039-0572241003905100 TABLET in 1 BOTTLE (72241-039-05) 100 tablet2021-10-050000-00-00NoNoCurrent
72241-039-1072241003910500 TABLET in 1 BOTTLE (72241-039-10) 500 tablet2021-10-050000-00-00NoNoCurrent
72241-039-11722410039111000 TABLET in 1 BOTTLE (72241-039-11) 1000 tablet2021-10-050000-00-00NoNoCurrent