glyburide and metformin hydrochloride

Product NDC: 68382-653
11-digit product format: 683820653
Labeler code: 68382
Product ID: 68382-653_05a184d3-8ed5-420f-8a0a-7a22c961d455
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glyburide and metformin hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals (USA) Inc.
Application: ANDA206748
Marketing category: ANDA
Marketing start: 2016-04-07
Substance: GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength: 1.25; 250 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29
A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29
A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206748-001	AB
A206748-002	AB
A206748-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-002	GLYBURIDE AND METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206748-003	GLYBURIDE AND METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET / ORAL	AB	2016-02-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206748-001	GLYBURIDE AND METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET / ORAL	AB	2016-02-29	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A206748-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206748-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206748-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206748-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206748-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206748-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206748-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206748-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206748-003	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: glyburide and metformin hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLYBURIDE	1.25 mg/1
METFORMIN HYDROCHLORIDE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
786Z46389E	Internal UNII lookup
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
861743	Internal RxNorm lookup
861748	Internal RxNorm lookup
861753	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
2239742b-74e1-4bc2-b5a8-15c4758d6f7b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6	Product name	2	20160609
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
5a2baaae-1290-c05e-207f-b1367e9eb46a	Product name	2	20151005
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
b044018d-bcdc-e68d-63da-1ad6886aea64	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68382-653-01	glyburide and metformin hydrochloride	100 in 1 BOTTLE	TABLET	100	6
68382-653-05	glyburide and metformin hydrochloride	500 in 1 BOTTLE	TABLET	500	6
68382-653-06	glyburide and metformin hydrochloride	30 in 1 BOTTLE	TABLET	30	6
68382-653-10	glyburide and metformin hydrochloride	1000 in 1 BOTTLE	TABLET	1000	6
68382-653-16	glyburide and metformin hydrochloride	90 in 1 BOTTLE	TABLET	90	6
68382-653-30	glyburide and metformin hydrochloride	10 in 1 BLISTER PACK	TABLET	10	6
68382-653-77	glyburide and metformin hydrochloride	10 in 1 CARTON	TABLET	10	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-653	GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	5	Current NDC, Legacy NDC, 7 package rows	20221117_2239742b-74e1-4bc2-b5a8-15c4758d6f7b.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 · 2 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	Zydus Pharmaceuticals (USA) Inc.	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206748 application number: ANDA206748 ndc (product): 68382-653
glyburide and metformin hydrochloride	GLYBURIDE AND METFORMIN HYDROCHLORIDE	Zydus Lifesciences Limited	df752bd4-e197-40a4-a01b-d48ba2c10516	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206748 application number: ANDA206748

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861743	glyBURIDE 1.25 MG / metFORMIN HCl 250 MG Oral Tablet	PSN	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861748	glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861753	glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861743	glyburide 1.25 MG / metformin hydrochloride 250 MG Oral Tablet	SCD	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861748	glyburide 2.5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861753	glyburide 5 MG / metformin hydrochloride 500 MG Oral Tablet	SCD	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6
861753	glyburide 5 MG / metformin HCl 500 MG Oral Tablet	SY	2239742b-74e1-4bc2-b5a8-15c4758d6f7b	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-653-01	68382065301	100 TABLET in 1 BOTTLE (68382-653-01)	100 tablet	2016-04-07	0000-00-00	No	No	Current
68382-653-05	68382065305	500 TABLET in 1 BOTTLE (68382-653-05)	500 tablet	2016-04-07	0000-00-00	No	No	Current
68382-653-06	68382065306	30 TABLET in 1 BOTTLE (68382-653-06)	30 tablet	2016-04-07	0000-00-00	No	No	Current
68382-653-10	68382065310	1000 TABLET in 1 BOTTLE (68382-653-10)	1000 tablet	2016-04-07	0000-00-00	No	No	Current
68382-653-16	68382065316	90 TABLET in 1 BOTTLE (68382-653-16)	90 tablet	2016-04-07	0000-00-00	No	No	Current
68382-653-30	68382065330	10 in 1 BLISTER PACK						Historical
68382-653-77	68382065377	10 BLISTER PACK in 1 CARTON (68382-653-77) / 10 TABLET in 1 BLISTER PACK (68382-653-30)	10 blister pack	2016-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glyburide and metformin hydrochloride	Zydus Pharmaceuticals (USA) Inc.	2026-06-10	HUMAN PRESCRIPTION DRUG LABEL	7