FDA.reportPublic FDA data

glyburide and metformin hydrochloride

Product NDC
68382-655
11-digit product format
683820655
Labeler code
68382
Product ID
68382-655_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
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 and 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
Rxcui861743, 861748, 861753

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

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
68382-655-0568382065505500 TABLET in 1 BOTTLE (68382-655-05) 500 tablet2016-04-070000-00-00NoNoCurrent
68382-655-066838206550630 TABLET in 1 BOTTLE (68382-655-06) 30 tablet2016-04-070000-00-00NoNoCurrent
68382-655-10683820655101000 TABLET in 1 BOTTLE (68382-655-10) 1000 tablet2016-04-070000-00-00NoNoCurrent
68382-655-166838206551690 TABLET in 1 BOTTLE (68382-655-16) 90 tablet2016-04-070000-00-00NoNoCurrent
68382-655-306838206553010 in 1 BLISTER PACKHistorical
68382-655-776838206557710 BLISTER PACK in 1 CARTON (68382-655-77) / 10 TABLET in 1 BLISTER PACK (68382-655-30) 10 blister pack2016-04-070000-00-00NoNoCurrent