Glyburide

Product NDC: 0093-8343
11-digit product format: 000938343
Labeler code: 0093
Product ID: 0093-8343_f4b5b433-1b6e-4af2-9d16-7194c2da041c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA074388
Marketing category: ANDA
Marketing start: 1995-08-30
Substance: GLYBURIDE
Active strength: 2.5 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	RLD / RS	Approval date
A074388-001	GLYBURIDE	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29
A074388-002	GLYBURIDE	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29
A074388-003	GLYBURIDE	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074388-001	AB1
A074388-002	AB1
A074388-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-002	GLYBURIDE	2.5MG	TABLET / ORAL	AB1		1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-003	GLYBURIDE	5MG	TABLET / ORAL	AB1	RS	1995-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074388-001	GLYBURIDE	1.25MG	TABLET / ORAL	AB1		1995-08-29	`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	A074388-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074388-003	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074388-003	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074388-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074388-003	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074388-003	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074388-003	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074388-003	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074388-003	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074388-003	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-001	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-002	AB1	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074388-003	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074388-001	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-002	AB1	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074388-003	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-001	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-002	AB1	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074388-003	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-001	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-002	AB1	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074388-003	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-001	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-002	AB1	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074388-003	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074388-001	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	2.5 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 · 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
a56f100f-0f42-4188-81ab-04644b824040	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	SPL version
0093-8343-01	Glyburide	100 in 1 BOTTLE	TABLET	100	18
0093-8343-05	Glyburide	500 in 1 BOTTLE	TABLET	500	18
0093-8343-10	Glyburide	1000 in 1 BOTTLE	TABLET	1000	18
0093-8343-98	Glyburide	90 in 1 BOTTLE	TABLET	90	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-8343-01	EA - Each	0093-8343	32eead26-cfae-4569-845d-48de95fcb5e1	1	2012-07-24
0093-8343-05	EA - Each	0093-8343	4e60e80d-a3d0-4775-8b6b-d7be0dd6d174	1	2012-07-24
0093-8343-10	EA - Each	0093-8343	3f9adfab-de0a-4099-a17e-c8c59d4d63aa	1	2012-07-24
0093-8343-98	EA - Each	0093-8343	41b3afec-44a4-48ef-9d6c-bc578a07295f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE TABLET [BRYANT RANCH PREPACK]	1001
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA INC]	14
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	11
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE TABLET [MYLAN INSTITUTIONAL INC.]	2
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GLYBURIDE (GLYBURIDE) TABLET [AVKARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-8343	GLYBURIDE TABLET [TEVA PHARMACEUTICALS USA, INC.]	18	Current NDC, Legacy NDC, 4 package rows	20211030_a56f100f-0f42-4188-81ab-04644b824040.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide	GLYBURIDE	Preferred Pharmaceuticals Inc.	bc8df889-25e0-49a0-bbec-a3dfae8bbb8a	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Coupler LLC	4573af7f-3c71-e323-e063-6394a90aa9eb	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Proficient Rx LP	6f65131c-90df-45ab-95fb-c36f411c6fbe	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	25516c2a-f1b5-9ee4-e063-6394a90ab46b	2024-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	NuCare Pharmaceuticals, Inc.	21786ac0-da3c-16cb-e063-6394a90a4596	2024-09-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	A-S Medication Solutions	922d1080-52c6-41e4-a310-533d8ca18594	2023-08-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Proficient Rx LP	ec45f0d8-cab8-4822-895b-17bb443a4f98	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388
Glyburide	GLYBURIDE	Teva Pharmaceuticals USA, Inc.	a56f100f-0f42-4188-81ab-04644b824040	2015-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074388 application number: ANDA074388 ndc (product): 0093-8343

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	a56f100f-0f42-4188-81ab-04644b824040	18
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	a56f100f-0f42-4188-81ab-04644b824040	18
310537	glyBURIDE 5 MG Oral Tablet	PSN	a56f100f-0f42-4188-81ab-04644b824040	18
197737	glyburide 1.25 MG Oral Tablet	SCD	a56f100f-0f42-4188-81ab-04644b824040	18
310534	glyburide 2.5 MG Oral Tablet	SCD	a56f100f-0f42-4188-81ab-04644b824040	18
310537	glyburide 5 MG Oral Tablet	SCD	a56f100f-0f42-4188-81ab-04644b824040	18
197737	glibenclamide 1.25 MG Oral Tablet	SY	a56f100f-0f42-4188-81ab-04644b824040	18
310534	glibenclamide 2.5 MG Oral Tablet	SY	a56f100f-0f42-4188-81ab-04644b824040	18
310537	glibenclamide 5 MG Oral Tablet	SY	a56f100f-0f42-4188-81ab-04644b824040	18
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	64a1ee72-cbe4-4558-899c-825c4b6d9435	11
310534	glyburide 2.5 MG Oral Tablet	SCD	64a1ee72-cbe4-4558-899c-825c4b6d9435	11
310534	glibenclamide 2.5 MG Oral Tablet	SY	64a1ee72-cbe4-4558-899c-825c4b6d9435	11
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	4b6b2ce1-e349-3921-e054-00144ff8d46c	4
310534	glyburide 2.5 MG Oral Tablet	SCD	4b6b2ce1-e349-3921-e054-00144ff8d46c	4
310534	glibenclamide 2.5 MG Oral Tablet	SY	4b6b2ce1-e349-3921-e054-00144ff8d46c	4
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	ec45f0d8-cab8-4822-895b-17bb443a4f98	3
310534	glyburide 2.5 MG Oral Tablet	SCD	ec45f0d8-cab8-4822-895b-17bb443a4f98	3
310534	glibenclamide 2.5 MG Oral Tablet	SY	ec45f0d8-cab8-4822-895b-17bb443a4f98	3
310534	glyBURIDE 2.5 MG Oral Tablet	PSN	4573af7f-3c71-e323-e063-6394a90aa9eb	1
310534	glyburide 2.5 MG Oral Tablet	SCD	4573af7f-3c71-e323-e063-6394a90aa9eb	1
310534	glibenclamide 2.5 MG Oral Tablet	SY	4573af7f-3c71-e323-e063-6394a90aa9eb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-8343-01	00093834301	100 TABLET in 1 BOTTLE (0093-8343-01)	100 tablet	1995-08-30	0000-00-00	No	No	Current
0093-8343-05	00093834305	500 TABLET in 1 BOTTLE (0093-8343-05)	500 tablet	1995-08-30	0000-00-00	No	No	Current
0093-8343-10	00093834310	1000 TABLET in 1 BOTTLE (0093-8343-10)	1000 tablet	1995-08-30	0000-00-00	No	No	Current
0093-8343-98	00093834398	90 TABLET in 1 BOTTLE (0093-8343-98)	90 tablet	2010-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	Coupler LLC	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	1
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	NuCare Pharmaceuticals, Inc.	2023-06-20	HUMAN PRESCRIPTION DRUG LABEL	4
GlyBURIDE Tablets, USP	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	A-S Medication Solutions	2021-02-09	HUMAN PRESCRIPTION DRUG LABEL	11
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	1005
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	Preferred Pharmaceuticals Inc.	2020-06-08	HUMAN PRESCRIPTION DRUG LABEL	4
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg Rx only	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	7
GLYBURIDE TABLETS USP 2.5,mg 8342 8343 8344 Rx only	Proficient Rx LP	2019-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	REMEDYREPACK INC.	2019-02-07	HUMAN PRESCRIPTION DRUG LABEL	3
GLYBURIDE TABLETS USP 1.25, 2.5, and 5 mg 8342 8343 8344 Rx only	Teva Pharmaceuticals USA, Inc.	2015-05-31	HUMAN PRESCRIPTION DRUG LABEL	18
GLYBURIDE TABLETS, USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2014-02-27	HUMAN PRESCRIPTION DRUG LABEL	11