Pioglitazone and metformin

Product NDC
0781-5626
Requested package NDC
0781-5626-66
11-digit product format
007815626
Labeler code
0781
Product ID
0781-5626_b7db37b9-778e-4835-809c-13a65f7e1d8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone and metformin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA091273
Marketing category
ANDA
Marketing start
2013-05-02
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength
15 mg/1; mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-56260781-5626-66DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16
A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-1684e616aacf4f…
2026-09-14 22:38:342026-08A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-04-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091273-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-04-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091273-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-04-1674a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091273-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091273-002AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091273-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091273-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091273-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A091273-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091273-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091273-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091273-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091273-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091273-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091273-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091273-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091273-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091273-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091273-002AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5626-60EA - Each0781-562690680cce-ef59-4a43-83d5-1c966a29132b12013-06-04

DailyMed Socrata Ingredients#

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861783pioglitazone 15 MG / metFORMIN HCl 500 MG Oral TabletPSN29145eca-d3de-475d-9171-3803966d6ba71
861783metformin hydrochloride 500 MG / pioglitazone 15 MG Oral TabletSCD29145eca-d3de-475d-9171-3803966d6ba71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5626-660078156266620 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-5626-66) 2013-05-020000-00-00NoNoCurrent