FDA.reportPublic FDA data

Pioglitazone HCL and Metformin HCL

Product NDC
13668-280
Requested package NDC
13668-280-10
11-digit product format
136680280
Labeler code
13668
Product ID
13668-280_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
500; 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

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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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
A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13
A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202001-001AB
A202001-002AB

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 22:38:342026-08A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-08-18 06:07:402026-07A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORAL2013-02-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORAL2013-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202001-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202001-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1374a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202001-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202001-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A202001-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202001-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202001-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202001-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202001-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202001-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202001-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202001-002AB16a471c1ec25d…
2019-12-13 00:20 UTC2019-12A202001-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202001-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A202001-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A202001-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202001-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A202001-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202001-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A202001-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202001-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A202001-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202001-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A202001-002AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202001-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202001-002AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone HCL and Metformin HCL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1
PIOGLITAZONE HYDROCHLORIDE15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JQT35NPK6CInternal UNII lookup
786Z46389EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861783Internal RxNorm lookup
861822Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237d8fa2-633c-4c29-84d3-f1b413610dc3Available on FDA.report

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, Related label table
NDCEffectiveRelated label
13668-280-052023-03-08These 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
13668-280-052023-03-08These 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
13668-280-102023-03-08These 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
13668-280-102023-03-08These 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
13668-280-332023-03-08These 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
13668-280-332023-03-08These 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
13668-280-602023-03-08These 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
13668-280-602023-03-08These 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
13668-280-742023-03-08These 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
13668-280-742023-03-08These 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
13668-280-052021-01-29These 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
13668-280-052021-01-29These 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
13668-280-102021-01-29These 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
13668-280-102021-01-29These 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
13668-280-332021-01-29These 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
13668-280-332021-01-29These 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
13668-280-602021-01-29These 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
13668-280-602021-01-29These 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
13668-280-742021-01-29These 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
13668-280-742021-01-29These 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
13668-280-05Pioglitazone HCL and Metformin HCL500 in 1 BOTTLETABLET5009
13668-280-10Pioglitazone HCL and Metformin HCL1000 in 1 BOTTLETABLET10009
13668-280-33Pioglitazone HCL and Metformin HCL180 in 1 BOTTLETABLET1809
13668-280-60Pioglitazone HCL and Metformin HCL60 in 1 BOTTLETABLET609
13668-280-74Pioglitazone HCL and Metformin HCL100 in 1 CARTONTABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-280-33EA - Each13668-280bc2c729b-4fd4-4b9a-8e63-04e17f0182db12013-03-03
13668-280-60EA - Each13668-2804cb43964-ded9-4652-9d73-a28d882d5ba712013-03-03

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202001
application number: ANDA202001
ndc (package): 13668-280-10
ndc (product): 13668-280
ndc11 (package): 13668028010

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
13668-280-10136680280101000 TABLET in 1 BOTTLE (13668-280-10) 1000 tablet2025-09-01NoNoCurrent