Pioglitazone Hydrochloride

Product NDC
50090-5582
11-digit product format
500905582
Labeler code
50090
Product ID
50090-5582_7ab290ed-2153-4768-b1a1-43242e158901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076798
Marketing category
ANDA
Marketing start
2020-10-28
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 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 productproduct50090-5582DDiscontinued by firm2026-08-07
excluded packagepackage50090-558250090-5582-0DDiscontinued by firm2026-08-07
excluded packagepackage50090-558250090-5582-1DDiscontinued 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 · 6 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 packagepackage50090-5582-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-5582-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5582-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-5582-0f5e01cc5f278…a2eaf40c39c3…

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
A076798-001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26
A076798-002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26
A076798-003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076798-001AB
A076798-002AB
A076798-003AB

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 UTC2026-02A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-002PIOGLITAZONE HYDROCHLORIDEEQ 30MG BASETABLET / ORALAB2012-10-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-003PIOGLITAZONE HYDROCHLORIDEEQ 45MG BASETABLET / ORALAB2012-10-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076798-001PIOGLITAZONE HYDROCHLORIDEEQ 15MG BASETABLET / ORALAB2012-10-268072bd15b7f6…

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 UTC2026-02A076798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076798-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076798-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076798-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076798-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076798-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076798-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076798-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076798-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076798-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076798-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076798-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076798-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076798-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076798-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076798-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076798-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076798-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076798-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5582PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC20230208_5ae36a91-1392-4aed-8e71-0cfbb6ff860a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEChartwell RX, LLC699e865a-952e-459e-a871-9b7cce475b712025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076798
application number: ANDA076798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5582-05009055820030 TABLET in 1 BOTTLE (50090-5582-0) 30 tablet2021-07-070000-00-00NoNoCurrent
50090-5582-15009055820190 TABLET in 1 BOTTLE (50090-5582-1) 90 tablet2021-07-070000-00-00NoNoCurrent