FDA.reportPublic FDA data

glyburide-metformin hydrochloride

Product NDC
23155-233
11-digit product format
231550233
Labeler code
23155
Product ID
23155-233_5b65cafb-4e53-4197-a872-c12ffdbc04e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glyburide-metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA079009
Marketing category
ANDA
Marketing start
2024-05-01
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 1.

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
A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03
A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03
A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079009-001AB
A079009-002AB
A079009-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-002GLYBURIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2009-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-003GLYBURIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2009-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079009-001GLYBURIDE AND METFORMIN HYDROCHLORIDE1.25MG;250MGTABLET / ORALAB2009-06-038072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A079009-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079009-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079009-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079009-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079009-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079009-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079009-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079009-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079009-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079009-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079009-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079009-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079009-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079009-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079009-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A079009-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079009-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079009-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079009-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079009-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYBURIDE1.25 mg/1
METFORMIN HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
786Z46389EInternal UNII lookup
SX6K58TVWCInternal 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
b38213bb-d663-4c95-a1b2-96c23ee5be09Available 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
23155-233-01glyburide-metformin hydrochloride100 in 1 BOTTLETABLET10015
23155-233-05glyburide-metformin hydrochloride500 in 1 BOTTLETABLET50015
23155-233-10glyburide-metformin hydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-233-01EA - Each23155-233093a1334-0e6e-4f42-906d-920fbac84e7012013-02-13
23155-233-05EA - Each23155-2332f447b2d-2377-4642-ad32-f3fe254c033412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
METFORMINACTIVE MOIETY9100L32L2NGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-233GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20240501_b38213bb-d663-4c95-a1b2-96c23ee5be09.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepackb5ccf5da-cbe1-4009-ba1c-990050838ee92026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEBryant Ranch Prepacka086cc29-cb5d-40d0-a57d-8e91f1aa91582026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b38213bb-d663-4c95-a1b2-96c23ee5be092026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
ndc (product): 23155-233
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsf43c087a-7135-4a79-8463-fe5e9319da912026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDENuCare Pharmaceuticals, Inc.486fec17-ff83-3bab-e063-6394a90a5ef02026-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009
glyburide-metformin hydrochlorideGLYBURIDE-METFORMIN HYDROCHLORIDEA-S Medication Solutionsfaa19e1b-2782-4bf1-a93f-84755f7aa53f2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079009
application number: ANDA079009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861743glyBURIDE 1.25 MG / metFORMIN HCl 250 MG Oral TabletPSNb38213bb-d663-4c95-a1b2-96c23ee5be0915
861748glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSNb38213bb-d663-4c95-a1b2-96c23ee5be0915
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNb38213bb-d663-4c95-a1b2-96c23ee5be0915
861743glyburide 1.25 MG / metformin hydrochloride 250 MG Oral TabletSCDb38213bb-d663-4c95-a1b2-96c23ee5be0915
861748glyburide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCDb38213bb-d663-4c95-a1b2-96c23ee5be0915
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDb38213bb-d663-4c95-a1b2-96c23ee5be0915
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYb38213bb-d663-4c95-a1b2-96c23ee5be0915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-233-0123155023301100 TABLET in 1 BOTTLE (23155-233-01) 100 tablet2024-05-010000-00-00NoNoCurrent
23155-233-0523155023305500 TABLET in 1 BOTTLE (23155-233-05) 500 tablet2024-05-010000-00-00NoNoCurrent
23155-233-10231550233101000 TABLET in 1 BOTTLE (23155-233-10) 1000 tablet2024-05-010000-00-00NoNoCurrent