Glyburide and Metformin Hydrochloride

Product NDC: 68788-9966
Requested package NDC: 68788-9966-8
11-digit product format: 687889966
Labeler code: 68788
Product ID: 68788-9966_df8e38eb-115e-490c-a9f0-a7990a13138c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Glyburide and Metformin Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA077870
Marketing category: ANDA
Marketing start: 2015-05-05
Marketing end: 0000-00-00
Substance: GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68788-9966	68788-9966-8	D	Discontinued by firm		2026-08-03

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 1 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14
A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14
A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077870-001	AB
A077870-002	AB
A077870-003	AB

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	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	RS	2007-11-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB		2007-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077870-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB		2007-11-14	`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	A077870-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077870-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077870-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077870-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077870-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077870-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077870-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077870-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077870-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077870-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077870-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077870-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077870-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077870-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077870-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077870-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077870-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077870-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077870-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077870-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-9966-1	EA - Each	68788-9966	5a8407e1-8ec4-459d-bffd-635405593671	1	2018-08-13
68788-9966-3	EA - Each	68788-9966	b3d46fa4-8c25-44a3-96bf-8f978a897d5c	1	2018-08-13
68788-9966-6	EA - Each	68788-9966	aebcd5e2-f286-4908-87a1-cbb3267fd4ac	1	2018-08-13
68788-9966-8	EA - Each	68788-9966	e546ebbe-fc2f-4137-8483-a39e492ce067	1	2018-08-13
68788-9966-9	EA - Each	68788-9966	8e4bbaf5-d7a9-4eea-8ddd-d3b1f0450441	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GLYBURIDE	ACTIVE INGREDIENT	SX6K58TVWC	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
GLYBURIDE	ACTIVE MOIETY	SX6K58TVWC	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
METFORMIN	ACTIVE MOIETY	9100L32L2N	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	1

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Rising Pharma Holdings, Inc.	372af566-d6ec-446f-88db-0b4cc83b577f	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Aurobindo Pharma Limited	7010b662-8b34-49ce-8e5b-73dee0821a60	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a58ff524-e975-4d51-a896-e869f8ea6624	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c284c146-436b-4eea-9dca-d7d21c82778c	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	A-S Medication Solutions	d87dade1-55fe-4e77-91b9-b642022a2b8a	2026-02-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Northwind Health Company, LLC	adb751e0-19f6-3f41-e053-2a95a90a2df8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	d2b109e4-b743-4c5b-98fa-8e1ff4491dd0	2025-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	4dcef36f-000e-43f5-8d67-0e2a079ab2c6	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7facb5ac-c1d5-43b4-e053-2991aa0a2a7b	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870
Glyburide and Metformin Hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Bryant Ranch Prepack	8f2951ab-20c3-4216-b250-4c6a62d32203	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077870 application number: ANDA077870

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SX6K58TVWC	GLYBURIDE	10238-21-8	GLYBURIDE
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9966-8	68788996608	120 TABLET, FILM COATED in 1 BOTTLE (68788-9966-8)	2015-05-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Glyburide and Metformin Hydrochloride	Preferred Pharmaceuticals Inc.	2020-06-05	HUMAN PRESCRIPTION DRUG LABEL	5