PIOGLITAZONEHYDROCHLORIDE

Product NDC
53002-1755
11-digit product format
530021755
Labeler code
53002
Product ID
53002-1755_050b9b36-78ef-4b7a-a938-acfa7b12ce09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONEHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091298
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
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53002-1755IInactivated by FDA2026-08-07
excluded packagepackage53002-175553002-1755-3IInactivated by FDA2026-08-07
excluded packagepackage53002-175553002-1755-9IInactivated by FDA2026-08-07

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 · 45 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 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-1755-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53002-1755-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1755-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53002-1755-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1755-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53002-1755-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1755-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53002-1755-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1755-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53002-1755-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1755-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53002-1755-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1755-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53002-1755-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1755-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53002-1755-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1755-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53002-1755-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-1755-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53002-1755-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-1755-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53002-1755-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-1755-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53002-1755-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-1755-38af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53002-1755-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-1755-3834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53002-1755-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-1755-31332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53002-1755-91332a3947898…d4bfe170f9cd…

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
A091298-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13
A091298-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13
A091298-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13

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 UTC2026-02A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091298-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORAL2013-02-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091298-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORAL2013-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091298-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORAL2013-02-138072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091298-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091298-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A091298-003AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A091298-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091298-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A091298-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091298-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091298-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A091298-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091298-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091298-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A091298-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091298-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091298-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A091298-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091298-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091298-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A091298-003AB1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1755-3PIOGLITAZONEHYDROCHLORIDE30 in 1 BOTTLETABLET304
53002-1755-9PIOGLITAZONEHYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1755PIOGLITAZONEHYDROCHLORIDE TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 2 package rows20210106_38011100-3203-4626-ba3b-81acd3a0f0f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone 45 MG Oral TabletPSN38011100-3203-4626-ba3b-81acd3a0f0f14
317573pioglitazone 15 MG Oral TabletSCD38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone 45 MG Oral TabletSCD38011100-3203-4626-ba3b-81acd3a0f0f14
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY38011100-3203-4626-ba3b-81acd3a0f0f14
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY38011100-3203-4626-ba3b-81acd3a0f0f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1755-35300217550330 TABLET in 1 BOTTLE (53002-1755-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-1755-95300217550990 TABLET in 1 BOTTLE (53002-1755-9) 90 tablet2018-10-010000-00-00NoNoCurrent