FDA.reportPublic FDA data

glyburide and metformin hydrochloride

Product NDC
68382-655
Requested package NDC
68382-655-01
11-digit product format
683820655
Labeler code
68382
Product ID
68382-655_10f3fa5d-7b0b-445b-8a83-7071295687af
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
5; 500 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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29
A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29
A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206748-001AB
A206748-002AB
A206748-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29c2088c7a36db…
2026-10-15 13:18:302026-09A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29c2088c7a36db…
2026-10-15 13:18:302026-09A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29c2088c7a36db…
2026-09-14 22:38:342026-08A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-2984e616aacf4f…
2026-09-14 22:38:342026-08A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-2984e616aacf4f…
2026-09-14 22:38:342026-08A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-2984e616aacf4f…
2026-08-18 06:07:402026-07A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29caaa826d4ba7…
2026-08-18 06:07:402026-07A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29caaa826d4ba7…
2026-08-18 06:07:402026-07A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A206748-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2016-02-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A206748-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2016-02-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206748-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2016-02-2979d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A206748-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206748-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206748-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206748-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206748-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206748-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206748-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206748-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206748-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206748-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206748-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206748-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206748-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206748-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206748-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206748-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206748-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206748-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206748-003AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206748-001AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206748-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206748-003AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206748-001AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206748-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206748-003AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206748-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206748-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206748-003AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206748-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206748-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206748-003AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206748-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A206748-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A206748-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206748-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A206748-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A206748-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206748-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206748-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206748-003AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE5 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SX6K58TVWCInternal UNII lookup
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861743Internal RxNorm lookup
861748Internal RxNorm lookup
861753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2239742b-74e1-4bc2-b5a8-15c4758d6f7bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
08b3e508-8c7e-3b95-0275-113510642fc6Product name220220309
3a90349e-ff2e-41bd-a106-b368fbc1c1f8Product name120200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86Product name120200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5Product name120190731
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
e1ede89f-54c8-428f-ae84-9e8a2deb67dbProduct name120180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cbProduct name120170224
988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
64b2b6e2-1c04-cf4a-db4c-078ed10e1dd6Product name220160609
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
5a2baaae-1290-c05e-207f-b1367e9eb46aProduct name220151005
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7Product name120150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0Product name120141205
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6Product name120140508
2de6e143-c970-2061-1b77-61c3aa8f4026Product name120140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776aProduct name120140508
b044018d-bcdc-e68d-63da-1ad6886aea64Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-655-01glyburide and metformin hydrochloride100 in 1 BOTTLETABLET1006
68382-655-05glyburide and metformin hydrochloride500 in 1 BOTTLETABLET5006
68382-655-06glyburide and metformin hydrochloride30 in 1 BOTTLETABLET306
68382-655-10glyburide and metformin hydrochloride1000 in 1 BOTTLETABLET10006
68382-655-16glyburide and metformin hydrochloride90 in 1 BOTTLETABLET906
68382-655-30glyburide and metformin hydrochloride10 in 1 BLISTER PACKTABLET106
68382-655-77glyburide and metformin hydrochloride10 in 1 CARTONTABLET106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-655GLYBURIDE AND METFORMIN HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 7 package rows20221117_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.2239742b-74e1-4bc2-b5a8-15c4758d6f7b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206748
application number: ANDA206748
ndc (package): 68382-655-01
ndc (product): 68382-655
ndc11 (package): 68382065501
glyburide and metformin hydrochlorideGLYBURIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteddf752bd4-e197-40a4-a01b-d48ba2c105162026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206748
application number: ANDA206748

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861743glyBURIDE 1.25 MG / metFORMIN HCl 250 MG Oral TabletPSN2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861748glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861743glyburide 1.25 MG / metformin hydrochloride 250 MG Oral TabletSCD2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861748glyburide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY2239742b-74e1-4bc2-b5a8-15c4758d6f7b6
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN5de677d1-f3eb-4019-9e6f-b1f4209f7bb75
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD5de677d1-f3eb-4019-9e6f-b1f4209f7bb75
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY5de677d1-f3eb-4019-9e6f-b1f4209f7bb75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-655-0168382065501100 TABLET in 1 BOTTLE (68382-655-01) 100 tablet2016-04-070000-00-00NoNoCurrent