FDA.reportPublic FDA data

glyburide-metformin hydrochloride

Product NDC
23155-235
11-digit product format
231550235
Labeler code
23155
Product ID
23155-235_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
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSX6K58TVWC, 786Z46389E

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
23155-235-01glyburide-metformin hydrochloride100 in 1 BOTTLETABLET10015
23155-235-05glyburide-metformin hydrochloride500 in 1 BOTTLETABLET50015
23155-235-10glyburide-metformin hydrochloride1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-235-01EA - Each23155-2355f610f72-402d-4a9e-8f87-bda4acc8f1e012013-02-13
23155-235-05EA - Each23155-235d8388876-5e86-4e5a-ab65-765ae7f7857212013-02-13

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
GLYBURIDEACTIVE INGREDIENTSX6K58TVWCGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
GLYBURIDEACTIVE MOIETYSX6K58TVWCGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
METFORMINACTIVE MOIETY9100L32L2NGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLYBURIDE-METFORMIN HYDROCHLORIDE TABLET [BLENHEIM PHARMACAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-235GLYBURIDE-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

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 TabletPSN486fec17-ff83-3bab-e063-6394a90a5ef015
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 hydrochloride 500 MG Oral TabletSCD486fec17-ff83-3bab-e063-6394a90a5ef015
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYb38213bb-d663-4c95-a1b2-96c23ee5be0915
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY486fec17-ff83-3bab-e063-6394a90a5ef015
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNf43c087a-7135-4a79-8463-fe5e9319da914
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDf43c087a-7135-4a79-8463-fe5e9319da914
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYf43c087a-7135-4a79-8463-fe5e9319da914
861748glyBURIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN0f530fcd-0ac0-3885-e054-00144ff88e882
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNa0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN0f530fcd-0ac0-3885-e054-00144ff88e882
861748glyburide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD0f530fcd-0ac0-3885-e054-00144ff88e882
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDa0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD0f530fcd-0ac0-3885-e054-00144ff88e882
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYa0ff8ee6-0da8-40f8-b5b0-a7b334e1a15f2
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSY0f530fcd-0ac0-3885-e054-00144ff88e882
861753glyBURIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSNb5ccf5da-cbe1-4009-ba1c-990050838ee91
861753glyburide 5 MG / metformin hydrochloride 500 MG Oral TabletSCDb5ccf5da-cbe1-4009-ba1c-990050838ee91
861753glyburide 5 MG / metformin HCl 500 MG Oral TabletSYb5ccf5da-cbe1-4009-ba1c-990050838ee91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-235-0123155023501100 TABLET in 1 BOTTLE (23155-235-01) 100 tablet2024-05-010000-00-00NoNoCurrent
23155-235-0523155023505500 TABLET in 1 BOTTLE (23155-235-05) 500 tablet2024-05-010000-00-00NoNoCurrent
23155-235-10231550235101000 TABLET in 1 BOTTLE (23155-235-10) 1000 tablet2024-05-010000-00-00NoNoCurrent