Glyburide

Product NDC: 68071-3452
11-digit product format: 680713452
Labeler code: 68071
Product ID: 68071-3452_48860991-6561-7756-e063-6394a90a7d01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA203379
Marketing category: ANDA
Marketing start: 2021-10-05
Substance: GLYBURIDE
Active strength: 5 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-3452-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-3452-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-3452-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-3452-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-3452-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-3452-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-3452-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-3452-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-3452-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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	Approval date
A203379-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04
A203379-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04
A203379-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203379-001	AB1
A203379-002	AB1
A203379-003	AB1

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1	2019-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	2019-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203379-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1	2019-01-04	`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	A203379-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203379-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203379-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203379-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203379-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203379-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203379-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203379-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203379-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203379-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203379-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203379-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203379-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203379-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203379-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203379-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203379-001	AB1	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Glyburide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYBURIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SX6K58TVWC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310537	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ffd31d06-6011-34e2-e053-6394a90a437f	Available on FDA.report

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-3452-3	2026-01-16	C162847	48780-1	2cef2736-7c4c-d83d-e063-dadaa90ab31f	GLYBURIDE TABLETS, USP For Oral Use 1.25, 2.5, and 5 mg
68071-3452-3	2025-01-30	C162847	48780-1	2cef2736-7c4c-d83d-e063-dadaa90ab31f	GLYBURIDE TABLETS, USP For Oral Use 1.25, 2.5, and 5 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3452-3	Glyburide	30 in 1 BOTTLE	TABLET	30		2
68071-3452-6	Glyburide	60 in 1 BOTTLE	TABLET	60		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3452	GLYBURIDE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Current NDC, 2 package rows	20230707_ffd31d06-6011-34e2-e053-6394a90a437f.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	REMEDYREPACK INC.	524eec41-37ee-419a-b7a1-d23e888ae6ab	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	REMEDYREPACK INC.	e23b9a3b-0184-4d1c-8e2c-668697a6da87	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	cf21c8c0-7247-4d5b-97f8-ae4016144642	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	51cf08e2-8a2f-4bde-996f-f431f1a68abd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	NuCare Pharmaceuticals,Inc.	ffd31d06-6011-34e2-e053-6394a90a437f	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379 ndc (product): 68071-3452
Glyburide	GLYBURIDE	Bryant Ranch Prepack	db074991-1267-454a-8b1d-b6f52e2132cc	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	676c0e45-0aa2-4060-ad18-67abb9873a50	2024-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	A-S Medication Solutions	d090f978-b1a5-4db7-951d-3f32dd06966c	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	Cadila Pharmaceuticals Limited	ea7a055b-64f0-46bf-aa8e-4a2ef5c3c035	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
Glyburide	GLYBURIDE	Modavar Pharmaceuticals LLC	a5de0ef6-4c8b-40ab-b0ed-2003a8086750	2022-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379
GLYBURIDE	GLYBURIDE	Nivagen Pharmaceuticals, Inc.	43c6f68b-5747-47c6-9538-51ef8c611db4	2021-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203379 application number: ANDA203379

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
310537	glyBURIDE 5 MG Oral Tablet	PSN	ffd31d06-6011-34e2-e053-6394a90a437f	2
310537	glyburide 5 MG Oral Tablet	SCD	ffd31d06-6011-34e2-e053-6394a90a437f	2
310537	glibenclamide 5 MG Oral Tablet	SY	ffd31d06-6011-34e2-e053-6394a90a437f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3452-3	68071345203	30 TABLET in 1 BOTTLE (68071-3452-3)	30 tablet	2023-07-06	No	No	Current
68071-3452-6	68071345206	60 TABLET in 1 BOTTLE (68071-3452-6)	60 tablet	2026-01-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYBURIDE TABLETS, USP For Oral Use 1.25, 2.5, and 5 mg	NuCare Pharmaceuticals,Inc.	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	2