Home NDC 0009-0352-04 Glynase
Product NDC 0009-0352
Requested package NDC 0009-0352-04
11-digit product format 000090352
Labeler code 0009
Product ID 0009-0352_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 3 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 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 · 11 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020051-001 GLYNASE GLYBURIDE 1.5MG TABLET / ORAL RLD 1992-03-04 N020051-002 GLYNASE GLYBURIDE 3MG TABLET / ORAL RLD 1992-03-04 N020051-003 GLYNASE GLYBURIDE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 N020051-004 GLYNASE GLYBURIDE 6MG TABLET / ORAL RLD 1993-09-24
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020051-001 GLYNASE 1.5MG TABLET / ORAL RLD 1992-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020051-002 GLYNASE 3MG TABLET / ORAL RLD 1992-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020051-004 GLYNASE 6MG TABLET / ORAL RLD 1993-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020051-001 GLYNASE 1.5MG TABLET / ORAL RLD 1992-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020051-002 GLYNASE 3MG TABLET / ORAL RLD 1992-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020051-004 GLYNASE 6MG TABLET / ORAL RLD 1993-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020051-001 GLYNASE 1.5MG TABLET / ORAL AB RLD 1992-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020051-002 GLYNASE 3MG TABLET / ORAL AB RLD 1992-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020051-003 GLYNASE 4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1993-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020051-004 GLYNASE 6MG TABLET / ORAL AB RLD, RS 1993-09-24 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0009-0352-04 00009035204 1000 TABLET in 1 BOTTLE, PLASTIC (0009-0352-04) 1000 tablet 1992-03-04 0000-00-00 No No Current