Pioglitazole and metformin hydrochloride

Product NDC
72162-2498
11-digit product format
721622498
Labeler code
72162
Product ID
72162-2498_3531ffd3-afc3-0fdf-e063-6394a90aebcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazole and metformin hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204802
Marketing category
ANDA
Marketing start
2015-11-06
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
Pioglitazole and metformin hydrochloride
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

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
72162-2498-2Pioglitazole and metformin hydrochloride180 in 1 BOTTLETABLET180100
72162-2498-6Pioglitazole and metformin hydrochloride60 in 1 BOTTLETABLET60100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2498-2EA - Each72162-249838be0841-2bfa-4332-8aba-38f9462d421912025-06-13
72162-2498-6EA - Each72162-249867450313-1975-4186-811e-2aacee68d0d412025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2498PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250519_bd9c05c9-278f-498d-881c-29ba1b60596e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861822pioglitazone 15 MG / metFORMIN HCl 850 MG Oral TabletPSNbd9c05c9-278f-498d-881c-29ba1b60596e100
861822metformin hydrochloride 850 MG / pioglitazone 15 MG Oral TabletSCDbd9c05c9-278f-498d-881c-29ba1b60596e100
861822metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYbd9c05c9-278f-498d-881c-29ba1b60596e100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2498-272162249802180 TABLET in 1 BOTTLE (72162-2498-2) 180 tablet2025-05-15NoNoHistorical
72162-2498-67216224980660 TABLET in 1 BOTTLE (72162-2498-6) 60 tablet2025-05-15NoNoHistorical