Glyburide

Product NDC
43063-433
11-digit product format
430630433
Labeler code
43063
Product ID
43063-433_e1fc32a7-7d30-17c3-e053-2995a90a4e7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA017532
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1984-05-01
Marketing end
0000-00-00
Substance
GLYBURIDE
Active strength
5 mg/1
Pharmacologic classes
Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-433DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-01DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-14DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-15DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-30DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-60DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-86DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-90DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-93DDiscontinued by firm2026-08-03
excluded packagepackage43063-43343063-433-98DDiscontinued 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 2 · 120 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 packagepackage43063-433-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-93d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-98d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43063-433-86d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-93f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-98f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43063-433-86f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-932ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-982ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43063-433-862ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-93a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-98a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43063-433-86a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-93cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-15cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-98cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43063-433-86cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-93cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-15cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-98cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43063-433-86cdf11ea48f46…ba0047e9e063…

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
N017532-001DIABETAGLYBURIDE1.25MGTABLET / ORALAB2RLD1984-05-01
N017532-002DIABETAGLYBURIDE2.5MGTABLET / ORALAB2RLD1984-05-01
N017532-003DIABETAGLYBURIDE5MGTABLET / ORALAB2RLD, RS1984-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017532-001AB2
N017532-002AB2
N017532-003AB2

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 UTC2026-02N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-012680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-015bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-0179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-01301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-002DIABETA2.5MGTABLET / ORALAB2RLD1984-05-011e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-003DIABETA5MGTABLET / ORALAB2RLD, RS1984-05-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017532-001DIABETA1.25MGTABLET / ORALAB2RLD1984-05-018072bd15b7f6…

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 UTC2026-02N017532-001AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017532-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-001AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017532-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017532-001AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017532-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-001AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017532-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-001AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017532-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-001AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017532-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-001AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017532-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-001AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017532-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-001AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017532-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017532-001AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10N017532-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-001AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017532-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-001AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017532-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-001AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017532-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017532-001AB218072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-433-14EA - Each43063-4334f1b76de-b2ee-4ca1-99ca-af033012e59212013-03-03
43063-433-30EA - Each43063-433c2354b19-7acd-4604-9e4b-b6a6ab28a67f12013-03-03
43063-433-60EA - Each43063-433bf540125-a2a7-4944-a59f-34e4c7a7425112019-01-24
43063-433-86EA - Each43063-4331c9fc769-e5a3-4ec9-9db1-2664bf9df20f12013-03-03
43063-433-90EA - Each43063-433d7a4dcfe-0c65-4c19-a4c0-42bc7e9900cd12013-05-02
43063-433-93EA - Each43063-4332d978cfa-76b4-4054-b8a3-d7f0e68cc6cd12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE TABLET [PD-RX PHARMACEUTICALS, INC.]6

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlyburideGLYBURIDETEVA Pharmaceuticals USA Inc50d16f1d-c814-4411-8749-62561321ecce2021-07-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 017532
application number: NDA017532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-433-0143063043301100 TABLET in 1 BOTTLE, PLASTIC (43063-433-01) 100 tablet2013-02-140000-00-00NoNoCurrent
43063-433-144306304331414 TABLET in 1 BOTTLE, PLASTIC (43063-433-14) 14 tablet2013-02-140000-00-00NoNoCurrent
43063-433-154306304331515 TABLET in 1 BOTTLE, PLASTIC (43063-433-15) 15 tablet2013-02-140000-00-00NoNoCurrent
43063-433-304306304333030 TABLET in 1 BOTTLE, PLASTIC (43063-433-30) 30 tablet2013-02-140000-00-00NoNoCurrent
43063-433-604306304336060 TABLET in 1 BOTTLE, PLASTIC (43063-433-60) 60 tablet2013-02-140000-00-00NoNoCurrent
43063-433-8643063043386360 TABLET in 1 BOTTLE, PLASTIC (43063-433-86) 360 tablet2013-02-140000-00-00NoNoCurrent
43063-433-904306304339090 TABLET in 1 BOTTLE, PLASTIC (43063-433-90) 90 tablet2013-02-140000-00-00NoNoCurrent
43063-433-9343063043393180 TABLET in 1 BOTTLE, PLASTIC (43063-433-93) 180 tablet2013-02-140000-00-00NoNoCurrent
43063-433-9843063043398120 TABLET in 1 BOTTLE, PLASTIC (43063-433-98) 120 tablet2013-02-140000-00-00NoNoCurrent