PIOGLITAZONE

Product NDC
16729-020
Requested package NDC
16729-020-10
11-digit product format
167290020
Labeler code
16729
Product ID
16729-020_83e09805-0fe4-ecd7-e053-2991aa0abb3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONE
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare, Inc.
Application
ANDA200044
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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]
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 packagepackage16729-02016729-020-10DDiscontinued by firm2026-08-07

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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200044-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13
A200044-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13
A200044-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200044-001AB
A200044-002AB
A200044-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2013-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200044-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2013-02-138072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200044-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200044-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200044-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200044-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200044-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200044-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200044-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200044-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200044-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200044-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200044-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200044-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200044-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200044-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200044-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200044-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200044-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200044-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200044-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200044-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-020-10EA - Each16729-02067f7e278-9f57-4d43-a703-637d7d523fa812013-03-03
16729-020-15EA - Each16729-02057b78e05-9fab-4748-9835-90efb394c24312013-03-03
16729-020-16EA - Each16729-020131da4de-5903-4699-b87c-70e23026e2d312013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3
pioglitazoneACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [ACCORD HEALTHCARE, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-020PIOGLITAZONE TABLET [ACCORD HEALTHCARE, INC.]9Legacy NDC20241004_8f2d7000-37ca-4e09-98ec-07d1c0354cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83
317573pioglitazone 15 MG Oral TabletSCD71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83
317573pioglitazone 15 MG Oral TabletPSNd05f6e91-07a4-658b-e053-2995a90af3601
317573pioglitazone 15 MG Oral TabletSCDd05f6e91-07a4-658b-e053-2995a90af3601
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYd05f6e91-07a4-658b-e053-2995a90af3601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-020-101672900201030 TABLET in 1 BOTTLE (16729-020-10) 30 tablet2013-02-130000-00-00NoNoCurrent