FDA.reportPublic FDA data

Pioglitazone HCL and Metformin HCL

Product NDC
13668-281
11-digit product format
136680281
Labeler code
13668
Product ID
13668-281_d3ee8181-154a-4042-91e9-18b51ddc8994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone HCL and Metformin HCL
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA202001
Marketing category
ANDA
Marketing start
2025-09-01
Substance
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength
850; 15 mg/1; mg/1
Pharmacologic classes
Biguanide [EPC], Biguanides [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone HCL and Metformin HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE850 mg/1
PIOGLITAZONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii786Z46389E, JQT35NPK6C
Rxcui861783, 861822

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
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
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
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
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
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13668-281-052023-03-08C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-332023-03-08C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-492023-03-08C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-602023-03-08C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-742023-03-08C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-052021-01-29C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-332021-01-29C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-492021-01-29C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-602021-01-29C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005
13668-281-742021-01-29C16284748780-1ba0f9c33-57a2-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE AND METFORMIN HYDROCHLORIDE TABLETS. PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Tablets , for oral use Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-281-05Pioglitazone HCL and Metformin HCL500 in 1 BOTTLETABLET5009
13668-281-33Pioglitazone HCL and Metformin HCL180 in 1 BOTTLETABLET1809
13668-281-49Pioglitazone HCL and Metformin HCL750 in 1 BOTTLETABLET7509
13668-281-60Pioglitazone HCL and Metformin HCL60 in 1 BOTTLETABLET609
13668-281-74Pioglitazone HCL and Metformin HCL100 in 1 CARTONTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-281-33EA - Each13668-281ab4f8b92-7cf5-4069-969f-f06a135748aa12013-03-03
13668-281-60EA - Each13668-281bb0b6ab5-cc10-4998-afc4-24dc3bb0d0fd12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
METFORMINACTIVE MOIETY9100L32L2NPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIOGLITAZONE HCL AND METFORMIN HCL TABLET [TORRENT PHARMACEUTICALS LIMITED]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861783pioglitazone 15 MG / metFORMIN HCl 500 MG Oral TabletPSN237d8fa2-633c-4c29-84d3-f1b413610dc39
861822pioglitazone 15 MG / metFORMIN HCl 850 MG Oral TabletPSN237d8fa2-633c-4c29-84d3-f1b413610dc39
861783metformin hydrochloride 500 MG / pioglitazone 15 MG Oral TabletSCD237d8fa2-633c-4c29-84d3-f1b413610dc39
861822metformin hydrochloride 850 MG / pioglitazone 15 MG Oral TabletSCD237d8fa2-633c-4c29-84d3-f1b413610dc39
861822metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY237d8fa2-633c-4c29-84d3-f1b413610dc39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-281-0513668028105500 TABLET in 1 BOTTLE (13668-281-05) 500 tablet2025-09-01NoNoCurrent
13668-281-3313668028133180 TABLET in 1 BOTTLE (13668-281-33) 180 tablet2025-09-01NoNoCurrent
13668-281-4913668028149750 TABLET in 1 BOTTLE (13668-281-49) 750 tablet2025-09-01NoNoCurrent
13668-281-601366802816060 TABLET in 1 BOTTLE (13668-281-60) 60 tablet2025-09-01NoNoCurrent
13668-281-7413668028174100 TABLET in 1 CARTON (13668-281-74) 100 tablet2025-09-01NoNoCurrent