Glynase

Product NDC
0009-3449
11-digit product format
000093449
Labeler code
0009
Product ID
0009-3449_03bce5d4-2e0d-41c5-8048-ceb4749b0b5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
Pharmacia and Upjohn Company LLC
Application
NDA020051
Marketing category
NDA
Marketing start
1992-03-04
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
6 mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0009-3449DDiscontinued by firm2026-08-03
excluded packagepackage0009-34490009-3449-01DDiscontinued by firm2026-08-03
excluded packagepackage0009-34490009-3449-03DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0009-3449-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0009-3449-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0009-3449-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0009-3449-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0009-3449-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0009-3449-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0009-3449-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0009-3449-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0009-3449-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0009-3449-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0009-3449-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0009-3449-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0009-3449-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0009-3449-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0009-3449-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0009-3449-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0009-3449-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0009-3449-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0009-3449-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0009-3449-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0009-3449-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0009-3449-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0009-3449-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0009-3449-03557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020051-001GLYNASEGLYBURIDE1.5MGTABLET / ORALRLD1992-03-04
N020051-002GLYNASEGLYBURIDE3MGTABLET / ORALRLD1992-03-04
N020051-003GLYNASEGLYBURIDE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24
N020051-004GLYNASEGLYBURIDE6MGTABLET / ORALRLD1993-09-24

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020051-001GLYNASE1.5MGTABLET / ORALRLD1992-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020051-002GLYNASE3MGTABLET / ORALRLD1992-03-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020051-004GLYNASE6MGTABLET / ORALRLD1993-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020051-001GLYNASE1.5MGTABLET / ORALRLD1992-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020051-002GLYNASE3MGTABLET / ORALRLD1992-03-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020051-004GLYNASE6MGTABLET / ORALRLD1993-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020051-001GLYNASE1.5MGTABLET / ORALABRLD1992-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020051-002GLYNASE3MGTABLET / ORALABRLD1992-03-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N020051-003GLYNASE4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1993-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10N020051-004GLYNASE6MGTABLET / ORALABRLD, RS1993-09-24d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08N020051-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020051-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020051-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020051-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020051-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020051-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020051-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020051-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020051-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020051-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020051-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020051-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020051-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020051-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020051-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020051-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020051-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020051-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020051-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020051-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020051-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020051-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020051-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N020051-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020051-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020051-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020051-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020051-001AB15d02ea3f76ae…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3449-01EA - Each0009-344947628247-fd1a-40ce-ac10-0cbf1b8ad51312012-07-24
0009-3449-03EA - Each0009-344944ac3b62-f799-42f0-8b8c-c404ff7f2ff612012-07-24

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-3449-0100009344901100 TABLET in 1 BOTTLE, PLASTIC (0009-3449-01) 100 tablet1992-03-040000-00-00NoNoCurrent
0009-3449-0300009344903500 TABLET in 1 BOTTLE, PLASTIC (0009-3449-03) 500 tablet1992-03-040000-00-00NoNoCurrent