Glyburide

Product NDC
63629-1393
Requested package NDC
63629-1393-6
11-digit product format
636291393
Labeler code
63629
Product ID
63629-1393_01c04386-c1d5-4fd9-bb05-37caf64516de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074388
Marketing category
ANDA
Marketing start
1995-08-30
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-139363629-1393-6DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…a55b01930146…

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
A074388-001GLYBURIDEGLYBURIDE1.25MGTABLET / ORALAB11995-08-29
A074388-002GLYBURIDEGLYBURIDE2.5MGTABLET / ORALAB11995-08-29
A074388-003GLYBURIDEGLYBURIDE5MGTABLET / ORALAB1RS1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074388-001AB1
A074388-002AB1
A074388-003AB1

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 UTC2026-02A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-002GLYBURIDE2.5MGTABLET / ORALAB11995-08-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-003GLYBURIDE5MGTABLET / ORALAB1RS1995-08-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074388-001GLYBURIDE1.25MGTABLET / ORALAB11995-08-298072bd15b7f6…

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 UTC2026-02A074388-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074388-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074388-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074388-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074388-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074388-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074388-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074388-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074388-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074388-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074388-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074388-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074388-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074388-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074388-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A074388-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074388-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074388-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074388-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074388-001AB118072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1393-1EA - Each63629-1393d0bf62c8-da35-4fd7-8aef-8374fa30da9212013-02-13
63629-1393-2EA - Each63629-13938c6a594b-a719-4673-b78f-65ab29cce51f12013-02-13
63629-1393-3EA - Each63629-139331125f44-3702-4c40-9048-92b3a40d572312013-02-13
63629-1393-4EA - Each63629-1393b5c3fe63-7a4d-4ad6-8345-f8cd4c76a52312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLYBURIDE TABLET [BRYANT RANCH PREPACK]1001

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDEPreferred Pharmaceuticals Inc.bc8df889-25e0-49a0-bbec-a3dfae8bbb8a2026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDECoupler LLC4573af7f-3c71-e323-e063-6394a90aa9eb2025-12-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDEProficient Rx LP6f65131c-90df-45ab-95fb-c36f411c6fbe2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.25516c2a-f1b5-9ee4-e063-6394a90ab46b2024-10-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.21786ac0-da3c-16cb-e063-6394a90a45962024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDEA-S Medication Solutions922d1080-52c6-41e4-a310-533d8ca185942023-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDEProficient Rx LPec45f0d8-cab8-4822-895b-17bb443a4f982019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388
GlyburideGLYBURIDETeva Pharmaceuticals USA, Inc.a56f100f-0f42-4188-81ab-04644b8240402015-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074388
application number: ANDA074388

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1393-663629139306180 TABLET in 1 BOTTLE (63629-1393-6) 180 tablet1995-08-300000-00-00NoNoCurrent