Pioglitazone Hydrochloride and Metformin Hydrochloride

Product NDC
65862-526
11-digit product format
658620526
Labeler code
65862
Product ID
65862-526_98930be0-b506-4a8c-8b1a-90117ac500c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone Hydrochloride and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200823
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength
15; 850 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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct65862-526UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage65862-52665862-526-38UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage65862-526-38a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage65862-526-381d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage65862-526-38390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage65862-526-38e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage65862-526-38bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage65862-526-38f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage65862-526-38f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage65862-526-3868b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage65862-526-3805c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage65862-526-3848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage65862-526-3827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage65862-526-388d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage65862-526-38d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage65862-526-3850b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage65862-526-38906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage65862-526-386db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage65862-526-388fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage65862-526-384184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage65862-526-384bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage65862-526-38263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage65862-526-385b2001dcd8f5…54b53d4dc9e4…

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
A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13
A200823-002PIOGLITAZONE 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
A200823-001AB
A200823-002AB

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 22:38:342026-08A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-09-14 22:38:342026-08A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1384e616aacf4f…
2026-08-18 06:07:402026-07A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-08-18 06:07:402026-07A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200823-001PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE500MG;EQ 15MG BASETABLET / ORALAB2013-02-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200823-002PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE850MG;EQ 15MG BASETABLET / ORALAB2013-02-1374a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A200823-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A200823-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A200823-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200823-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200823-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200823-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200823-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200823-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200823-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200823-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200823-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200823-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200823-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200823-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200823-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200823-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200823-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200823-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200823-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200823-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200823-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200823-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200823-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200823-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200823-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200823-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200823-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200823-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200823-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200823-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200823-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200823-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200823-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200823-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200823-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200823-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200823-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200823-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200823-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200823-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1
METFORMIN HYDROCHLORIDE850 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
1fa2703e-fb73-44d5-aaa2-b12b1090d42cAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-526-18Pioglitazone Hydrochloride and Metformin Hydrochloride180 in 1 BOTTLETABLET, FILM COATED18014
65862-526-60Pioglitazone Hydrochloride and Metformin Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-526-18EA - Each65862-526b6cc15a5-2c75-449a-a55a-eeebcbedc6ac12013-03-03
65862-526-60EA - Each65862-5264246d45c-a67b-4602-a5b9-8dae41daa0cd12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METFORMIN HYDROCHLORIDEACTIVE INGREDIENT786Z46389EPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
METFORMINACTIVE MOIETY9100L32L2NPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TALCINACTIVE INGREDIENT7SEV7J4R1UPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-526PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 2 package rows20250302_1fa2703e-fb73-44d5-aaa2-b12b1090d42c.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200823
application number: ANDA200823
ndc (product): 65862-526
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.8d252dab-e868-42d3-95ea-69423d909e842025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200823
application number: ANDA200823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861783pioglitazone 15 MG / metFORMIN HCl 500 MG Oral TabletPSN1fa2703e-fb73-44d5-aaa2-b12b1090d42c14
861822pioglitazone 15 MG / metFORMIN HCl 850 MG Oral TabletPSN1fa2703e-fb73-44d5-aaa2-b12b1090d42c14
861783metformin hydrochloride 500 MG / pioglitazone 15 MG Oral TabletSCD1fa2703e-fb73-44d5-aaa2-b12b1090d42c14
861822metformin hydrochloride 850 MG / pioglitazone 15 MG Oral TabletSCD1fa2703e-fb73-44d5-aaa2-b12b1090d42c14
861822metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY1fa2703e-fb73-44d5-aaa2-b12b1090d42c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-526-1865862052618180 TABLET, FILM COATED in 1 BOTTLE (65862-526-18) 2013-02-130000-00-00NoNoCurrent
65862-526-38658620526381800 TABLET, FILM COATED in 1 BAG (65862-526-38)13-FEB-13Current
65862-526-606586205266060 TABLET, FILM COATED in 1 BOTTLE (65862-526-60) 2013-02-130000-00-00NoNoCurrent