GLYBURIDE

Product NDC: 75834-202
11-digit product format: 758340202
Labeler code: 75834
Product ID: 75834-202_757b12d9-8efb-49ca-b8f7-7884535ca011
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: GLYBURIDE
Dosage form: TABLET
Route: ORAL
Labeler: Nivagen Pharmaceuticals, Inc.
Application: ANDA203379
Marketing category: ANDA
Marketing start: 2019-01-25
Substance: GLYBURIDE
Active strength: 1.25 mg/1
Pharmacologic classes: Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYBURIDE	1.25 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197737	Internal RxNorm lookup
310534	Internal RxNorm lookup
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
43c6f68b-5747-47c6-9538-51ef8c611db4	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75834-202-00	GLYBURIDE	1000 in 1 BOTTLE	TABLET	1000		2
75834-202-01	GLYBURIDE	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
75834-202-01	EA - Each	75834-202	547a8557-ca5f-48f8-8095-0abb39797235	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75834-202	GLYBURIDE TABLET [NIVAGEN PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20210115_43c6f68b-5747-47c6-9538-51ef8c611db4.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
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 ndc (product): 75834-202

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	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310537	glyBURIDE 5 MG Oral Tablet	PSN	43c6f68b-5747-47c6-9538-51ef8c611db4	2
197737	glyburide 1.25 MG Oral Tablet	SCD	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310534	glyburide 2.5 MG Oral Tablet	SCD	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310537	glyburide 5 MG Oral Tablet	SCD	43c6f68b-5747-47c6-9538-51ef8c611db4	2
197737	glibenclamide 1.25 MG Oral Tablet	SY	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310534	glibenclamide 2.5 MG Oral Tablet	SY	43c6f68b-5747-47c6-9538-51ef8c611db4	2
310537	glibenclamide 5 MG Oral Tablet	SY	43c6f68b-5747-47c6-9538-51ef8c611db4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75834-202-00	75834020200	1000 TABLET in 1 BOTTLE (75834-202-00)	1000 tablet	2019-01-25	0000-00-00	No	No	Current
75834-202-01	75834020201	100 TABLET in 1 BOTTLE (75834-202-01)	100 tablet	2019-01-25	0000-00-00	No	No	Current