FDA.reportPublic FDA data

Glipizide and Metformin Hydrochloride

Product NDC
0093-7456
11-digit product format
000937456
Labeler code
0093
Product ID
0093-7456_50580ebe-be6b-439b-a39d-6536b9125fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glipizide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077270
Marketing category
ANDA
Marketing start
2005-10-28
Substance
GLIPIZIDE; METFORMIN HYDROCHLORIDE
Active strength
2.5; 500 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Sulfonylurea Compounds [CS], Sulfonylurea [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glipizide and Metformin Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLIPIZIDE2.5 mg/1
METFORMIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX7WDT95N5C, 786Z46389E
Rxcui861731, 861736, 861740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6a29d87d-f465-752d-5fa9-bd728c608ca2Product name420251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698eProduct name120250724
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a985afd1-89a8-bfab-0231-b59db1a3a9b5Product name720250515
25bfaa4d-02a1-402c-96ec-9bf6e625484cProduct name120250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0Product name220240829
16dbe107-66d5-47b3-57ed-0cba6a8dfcccProduct name620240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
b1de1ca9-d9db-4f4b-2103-09e2014d30d5Product name520180912
ca3f036c-6c06-b829-b379-1a3a4097099cProduct name920180605
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5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52cProduct name220170824
bea938a6-c880-985b-d27b-b59b0d8b5a77Product name320170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2fProduct name120170616
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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988f737f-e7e9-4613-8558-824b1ab755f9Product name120161128
58b66776-50d5-434f-916f-958ccf131e0eProduct name120160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
2988466d-5fc4-4430-9cee-fc9132f02d2cProduct name120150910
85cbb42f-1a8d-f945-f85e-188e823b7f5bProduct name220150731
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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
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7456-01Glipizide and Metformin Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7456-01EA - Each0093-7456e7f72f79-896d-45cd-84a0-ca97caa9cb4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
METFORMINACTIVE MOIETY9100L32L2NGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
TALCINACTIVE INGREDIENT7SEV7J4R1UGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
METFORMINACTIVE MOIETY9100L32L2NGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.]2
GLIPIZIDEACTIVE INGREDIENTX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
GLIPIZIDEACTIVE MOIETYX7WDT95N5CGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
METFORMINACTIVE MOIETY9100L32L2NGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7456GLIPIZIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 1 package rows20220105_03d9ce02-0559-494c-a53d-de9b9a64b606.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861731glipiZIDE 2.5 MG / metFORMIN HCl 250 MG Oral TabletPSN03d9ce02-0559-494c-a53d-de9b9a64b60618
861736glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN03d9ce02-0559-494c-a53d-de9b9a64b60618
861740glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN03d9ce02-0559-494c-a53d-de9b9a64b60618
861731glipizide 2.5 MG / metformin hydrochloride 250 MG Oral TabletSCD03d9ce02-0559-494c-a53d-de9b9a64b60618
861736glipizide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD03d9ce02-0559-494c-a53d-de9b9a64b60618
861740glipizide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD03d9ce02-0559-494c-a53d-de9b9a64b60618
861736glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSNae9a4e65-4613-42cf-a310-0fce9f1f93e812
861736glipizide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCDae9a4e65-4613-42cf-a310-0fce9f1f93e812
861736glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN13be49d2-0ce9-a78a-e557-ded85ddc808f9
861740glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN13be49d2-0ce9-a78a-e557-ded85ddc808f9
861736glipizide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD13be49d2-0ce9-a78a-e557-ded85ddc808f9
861740glipizide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD13be49d2-0ce9-a78a-e557-ded85ddc808f9
861731glipiZIDE 2.5 MG / metFORMIN HCl 250 MG Oral TabletPSN59909d47-da42-411c-8e79-fc867974a2831
861736glipiZIDE 2.5 MG / metFORMIN HCl 500 MG Oral TabletPSN59909d47-da42-411c-8e79-fc867974a2831
861740glipiZIDE 5 MG / metFORMIN HCl 500 MG Oral TabletPSN59909d47-da42-411c-8e79-fc867974a2831
861731glipizide 2.5 MG / metformin hydrochloride 250 MG Oral TabletSCD59909d47-da42-411c-8e79-fc867974a2831
861736glipizide 2.5 MG / metformin hydrochloride 500 MG Oral TabletSCD59909d47-da42-411c-8e79-fc867974a2831
861740glipizide 5 MG / metformin hydrochloride 500 MG Oral TabletSCD59909d47-da42-411c-8e79-fc867974a2831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7456-0100093745601100 TABLET, FILM COATED in 1 BOTTLE (0093-7456-01) 2005-10-280000-00-00NoNoCurrent