FDA.reportPublic FDA data

Actoplus Met

Product NDC
64764-158
11-digit product format
647640158
Labeler code
64764
Product ID
64764-158_271ff8ce-9ae5-4b65-8581-7ced42f47f2f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone and metformin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Takeda Pharmaceuticals America, Inc.
Application
NDA021842
Marketing category
NDA
Marketing start
2005-08-29
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
Actoplus Met
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
Rxcui861822, 861824

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64764-158-18Actoplus Met180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18027
64764-158-41Actoplus Met4 in 1 TRAYTABLET, FILM COATED427
64764-158-41Actoplus Met1 in 1 CARTONTABLET, FILM COATED127
64764-158-60Actoplus Met60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64764-158-18EA - Each64764-158e1a75bec-b4b6-410d-a335-53532804cfb712012-07-24
64764-158-60EA - Each64764-1582fd7f3b0-f33b-41d1-9171-938f887e060112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
metformin hydrochlorideACTIVE INGREDIENT786Z46389EACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
metforminACTIVE MOIETY9100L32L2NACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
pioglitazoneACTIVE MOIETYX4OV71U42SACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
hypromellose 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
magnesium stearateINACTIVE INGREDIENT70097M6I30ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
POVIDONESINACTIVE INGREDIENTFZ989GH94EACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
talcINACTIVE INGREDIENT7SEV7J4R1UACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]14
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
METFORMINACTIVE MOIETY9100L32L2NACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
PIOGLITAZONEACTIVE MOIETYX4OV71U42SACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64764-158ACTOPLUS MET (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]27Current NDC, Legacy NDC, 4 package rows20250406_42e49120-6f3f-11db-9fe1-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861824actoplus met 15 MG / 850 MG Oral TabletPSN42e49120-6f3f-11db-9fe1-0800200c9a6627
861822pioglitazone 15 MG / metFORMIN HCl 850 MG Oral TabletPSN42e49120-6f3f-11db-9fe1-0800200c9a6627
861824metformin hydrochloride 850 MG / pioglitazone 15 MG Oral Tablet [Actoplus Met]SBD42e49120-6f3f-11db-9fe1-0800200c9a6627
861822metformin hydrochloride 850 MG / pioglitazone 15 MG Oral TabletSCD42e49120-6f3f-11db-9fe1-0800200c9a6627
861824Actoplus Met 15/850 (metformin hydrochloride 850 MG / pioglitazone (as pioglitazone hydrochloride) 15 MG) Oral TabletSY42e49120-6f3f-11db-9fe1-0800200c9a6627
861824Actoplus Met 15/850 MG Oral TabletSY42e49120-6f3f-11db-9fe1-0800200c9a6627
861822metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY42e49120-6f3f-11db-9fe1-0800200c9a6627
861785actoplus met 15 MG / 500 MG Oral TabletPSNf5c534e8-656c-406d-b3dc-b562576ba4eb2
861824actoplus met 15 MG / 850 MG Oral TabletPSNf5c534e8-656c-406d-b3dc-b562576ba4eb2
861783pioglitazone 15 MG / metFORMIN HCl 500 MG Oral TabletPSNf5c534e8-656c-406d-b3dc-b562576ba4eb2
861822pioglitazone 15 MG / metFORMIN HCl 850 MG Oral TabletPSNf5c534e8-656c-406d-b3dc-b562576ba4eb2
861785metformin hydrochloride 500 MG / pioglitazone 15 MG Oral Tablet [Actoplus Met]SBDf5c534e8-656c-406d-b3dc-b562576ba4eb2
861824metformin hydrochloride 850 MG / pioglitazone 15 MG Oral Tablet [Actoplus Met]SBDf5c534e8-656c-406d-b3dc-b562576ba4eb2
861783metformin hydrochloride 500 MG / pioglitazone 15 MG Oral TabletSCDf5c534e8-656c-406d-b3dc-b562576ba4eb2
861822metformin hydrochloride 850 MG / pioglitazone 15 MG Oral TabletSCDf5c534e8-656c-406d-b3dc-b562576ba4eb2
861785Actoplus Met 15/500 (metformin hydrochloride 500 MG / pioglitazone (as pioglitazone hydrochloride) 15 MG) Oral TabletSYf5c534e8-656c-406d-b3dc-b562576ba4eb2
861785Actoplus Met 15/500 MG Oral TabletSYf5c534e8-656c-406d-b3dc-b562576ba4eb2
861824Actoplus Met 15/850 (metformin hydrochloride 850 MG / pioglitazone (as pioglitazone hydrochloride) 15 MG) Oral TabletSYf5c534e8-656c-406d-b3dc-b562576ba4eb2
861824Actoplus Met 15/850 MG Oral TabletSYf5c534e8-656c-406d-b3dc-b562576ba4eb2
861822metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYf5c534e8-656c-406d-b3dc-b562576ba4eb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64764-158-1864764015818180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-18) 2005-08-290000-00-00NoNoCurrent
64764-158-41647640158414 CARTON in 1 TRAY (64764-158-41) / 1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK4 carton2005-08-290000-00-00NoNoCurrent
64764-158-606476401586060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-158-60) 2005-08-290000-00-00NoNoCurrent