Glyburide

Product NDC: 43353-656
11-digit product format: 433530656
Labeler code: 43353
Product ID: 43353-656_450c5c16-46d8-4867-8f8b-c84dd8515761
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glyburide
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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 [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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-656		I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-53	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-60	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-70	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-80	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-90	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-92	I	Inactivated by FDA	2026-08-07
excluded package	package	43353-656	43353-656-94	I	Inactivated by FDA	2026-08-07

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-94	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-53	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-92	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-656-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-94	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-53	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-92	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-656-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-94	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-53	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-92	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-656-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-94	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-53	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-92	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-656-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-94	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-53	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-92	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-656-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-94	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-53	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-92	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-656-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-94	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-53	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-92	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-656-90	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-656-94	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-656-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-656-53	`ed331223b511…`	`672a5bd82f5f…`

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017532-001	DIABETA	GLYBURIDE	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01
N017532-002	DIABETA	GLYBURIDE	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01
N017532-003	DIABETA	GLYBURIDE	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01

Therapeutic equivalence codes#

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

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

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
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	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-002	DIABETA	2.5MG	TABLET / ORAL	AB2	RLD	1984-05-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-003	DIABETA	5MG	TABLET / ORAL	AB2	RLD, RS	1984-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017532-001	DIABETA	1.25MG	TABLET / ORAL	AB2	RLD	1984-05-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017532-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017532-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017532-003	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017532-003	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017532-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017532-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017532-003	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017532-003	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017532-003	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017532-003	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017532-003	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017532-003	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-001	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-002	AB2	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017532-003	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017532-001	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017532-002	AB2	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017532-003	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-001	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-002	AB2	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017532-003	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-001	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-002	AB2	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017532-003	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-001	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-002	AB2	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017532-003	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017532-001	AB2	1	`8072bd15b7f6…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6	Product name	2	20160609
5a2baaae-1290-c05e-207f-b1367e9eb46a	Product name	2	20151005
b044018d-bcdc-e68d-63da-1ad6886aea64	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43353-656-53	Glyburide Tablets USP
43353-656-60	Glyburide Tablets USP
43353-656-70	Glyburide Tablets USP
43353-656-80	Glyburide Tablets USP
43353-656-90	Glyburide Tablets USP
43353-656-92	Glyburide Tablets USP
43353-656-94	Glyburide Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-656-53	Glyburide	60 in 1 BOTTLE, PLASTIC	TABLET	60	3
43353-656-60	Glyburide	90 in 1 BOTTLE, PLASTIC	TABLET	90	3
43353-656-70	Glyburide	120 in 1 BOTTLE, PLASTIC	TABLET	120	3
43353-656-80	Glyburide	180 in 1 BOTTLE, PLASTIC	TABLET	180	3
43353-656-90	Glyburide	240 in 1 BOTTLE, PLASTIC	TABLET	240	3
43353-656-92	Glyburide	270 in 1 BOTTLE, PLASTIC	TABLET	270	3
43353-656-94	Glyburide	360 in 1 BOTTLE, PLASTIC	TABLET	360	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-656-53	EA - Each	43353-656	0f651bd3-ddc2-456a-aec0-315b5eb411d6	1	2014-06-03
43353-656-60	EA - Each	43353-656	7d8c7f29-e7aa-4dcc-9901-cef488e2c101	1	2014-06-03
43353-656-70	EA - Each	43353-656	48ff5306-745d-4118-a2f2-99ec858e13d1	1	2014-06-03
43353-656-80	EA - Each	43353-656	b80d0cfa-ee4c-4dd5-8e9d-14b80a516c17	1	2014-06-03
43353-656-90	EA - Each	43353-656	8895d8ce-2b0c-4457-9382-02754acec198	1	2014-06-03
43353-656-92	EA - Each	43353-656	f4b3c248-722c-45ee-b7ca-5536513c06de	1	2014-06-03
43353-656-94	EA - Each	43353-656	d2b42343-bc24-480f-8016-9b469f4c9098	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
glyburide	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
glyburide	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
calcium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	L11K75P92J	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C Blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
FD&C Red no. 40	INACTIVE INGREDIENT	WZB9127XOA	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
sodium alginate	INACTIVE INGREDIENT	C269C4G2ZQ	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-656	GLYBURIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 7 package rows	20191224_820400e2-d340-416d-9015-c56357780362.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	TEVA Pharmaceuticals USA Inc	50d16f1d-c814-4411-8749-62561321ecce	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017532 application number: NDA017532

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SX6K58TVWC	GLYBURIDE	10238-21-8	GLYBURIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197737	glyBURIDE 1.25 MG Oral Tablet	PSN	820400e2-d340-416d-9015-c56357780362	3
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	820400e2-d340-416d-9015-c56357780362	3
310537	glyBURIDE 5 MG Oral Tablet	PSN	820400e2-d340-416d-9015-c56357780362	3
197737	glyburide 1.25 MG Oral Tablet	SCD	820400e2-d340-416d-9015-c56357780362	3
310534	glyburide 2.5 MG Oral Tablet	SCD	820400e2-d340-416d-9015-c56357780362	3
310537	glyburide 5 MG Oral Tablet	SCD	820400e2-d340-416d-9015-c56357780362	3
197737	glibenclamide 1.25 MG Oral Tablet	SY	820400e2-d340-416d-9015-c56357780362	3
310534	glibenclamide 2.5 MG Oral Tablet	SY	820400e2-d340-416d-9015-c56357780362	3
310537	glibenclamide 5 MG Oral Tablet	SY	820400e2-d340-416d-9015-c56357780362	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-656-53	43353065653	60 TABLET in 1 BOTTLE, PLASTIC (43353-656-53)	60 tablet	2010-08-20	0000-00-00	No	No	Current
43353-656-60	43353065660	90 TABLET in 1 BOTTLE, PLASTIC (43353-656-60)	90 tablet	2010-01-14	0000-00-00	No	No	Current
43353-656-70	43353065670	120 TABLET in 1 BOTTLE, PLASTIC (43353-656-70)	120 tablet	2010-08-20	0000-00-00	No	No	Current
43353-656-80	43353065680	180 TABLET in 1 BOTTLE, PLASTIC (43353-656-80)	180 tablet	2010-08-20	0000-00-00	No	No	Current
43353-656-90	43353065690	240 TABLET in 1 BOTTLE, PLASTIC (43353-656-90)	240 tablet	2010-08-20	0000-00-00	No	No	Current
43353-656-92	43353065692	270 TABLET in 1 BOTTLE, PLASTIC (43353-656-92)	270 tablet	2010-08-20	0000-00-00	No	No	Current
43353-656-94	43353065694	360 TABLET in 1 BOTTLE, PLASTIC (43353-656-94)	360 tablet	2010-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glyburide Tablets USP	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	3