Glyburide

Product NDC
68071-5030
11-digit product format
680715030
Labeler code
68071
Product ID
68071-5030_1b40ebf8-6634-f765-e063-6294a90a93cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090937
Marketing category
ANDA
Marketing start
2010-10-05
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-5030-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-5030-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-5030-01332a3947898…d4bfe170f9cd…

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
A090937-001GLYBURIDEGLYBURIDE1.25MGTABLET / ORALAB12011-02-28
A090937-002GLYBURIDEGLYBURIDE2.5MGTABLET / ORALAB12011-02-28
A090937-003GLYBURIDEGLYBURIDE5MGTABLET / ORALAB12011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090937-001AB1
A090937-002AB1
A090937-003AB1

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 UTC2026-02A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-002GLYBURIDE2.5MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-003GLYBURIDE5MGTABLET / ORALAB12011-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090937-001GLYBURIDE1.25MGTABLET / ORALAB12011-02-288072bd15b7f6…

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 UTC2026-02A090937-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090937-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090937-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090937-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090937-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090937-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090937-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090937-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090937-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090937-003AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090937-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090937-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090937-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090937-003AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-002AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090937-003AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-002AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090937-003AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090937-001AB118072bd15b7f6…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
901c50d5-31e7-b073-e053-2995a90abfebAvailable 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5030-0Glyburide100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5030GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240620_901c50d5-31e7-b073-e053-2995a90abfeb.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYBURIDEGLYBURIDEBryant Ranch Prepack9cdd30e7-512a-4f00-a4de-0a154d143ce92026-05-18Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENorthwind Health Company, LLCd9cb9251-7b31-72a0-e053-2a95a90a43152026-01-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENorthwind Health Company, LLCdb47a517-f8bb-136f-e053-2a95a90ad8c52026-01-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEChartwell RX, LLC7e661288-2d24-4403-86a1-754afa1d04ff2025-12-09Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.33418bba-c5ea-4c0f-9d28-31dc2724c6c32025-10-31Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.7ee41cd3-461f-3408-e053-2991aa0a863d2025-02-06Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEBryant Ranch Prepack05341afe-5b7a-462a-a196-689cb09f83fc2025-01-28Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals, Inc.3e354b4d-70e4-5089-e054-00144ff88e882024-08-13Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a12342fb-123c-2951-e053-2a95a90ac5962024-06-20Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.a1233548-bbb8-34aa-e053-2a95a90aea532024-06-20Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDENuCare Pharmaceuticals,Inc.901c50d5-31e7-b073-e053-2995a90abfeb2024-06-19Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
ndc (product): 68071-5030
GLYBURIDEGLYBURIDEA-S Medication Solutions7a280f88-26d4-4fe5-a89b-a6f1d90ed3cd2023-12-03Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GLYBURIDEGLYBURIDEA-S Medication Solutions3c91a408-973b-4572-832f-515f61d5be1f2023-02-04Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDEProficient Rx LPb292cb9b-7348-4c07-a871-bc091229fdf82019-11-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937
GlyburideGLYBURIDEProficient Rx LP240c3ac6-9aab-4185-994e-a0254e3aeb612019-11-01Adverse reactionsExact identifier
application applno (ANDA): 090937
application number: ANDA090937

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310537glyBURIDE 5 MG Oral TabletPSN901c50d5-31e7-b073-e053-2995a90abfeb3
310537glyburide 5 MG Oral TabletSCD901c50d5-31e7-b073-e053-2995a90abfeb3
310537glibenclamide 5 MG Oral TabletSY901c50d5-31e7-b073-e053-2995a90abfeb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5030-068071503000100 TABLET in 1 BOTTLE (68071-5030-0) 100 tablet2019-08-140000-00-00NoNoCurrent