Pioglitazone Hydrochloride

Product NDC
63629-3299
11-digit product format
636293299
Labeler code
63629
Product ID
63629-3299_2901274a-6e9a-49cf-9fa4-27f099a71b3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200044
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3299DDiscontinued by firm2026-08-07
excluded packagepackage63629-329963629-3299-1DDiscontinued by firm2026-08-07
excluded packagepackage63629-329963629-3299-2DDiscontinued by firm2026-08-07
excluded packagepackage63629-329963629-3299-3DDiscontinued by firm2026-08-07
excluded packagepackage63629-329963629-3299-4DDiscontinued 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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3299-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3299-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3299-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3299-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3299-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3299-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3299-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3299-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-3299-2IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-3299-3IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-3299-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3299-2IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3299-3IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-3299-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3299-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3299-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-3299-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3299-12021-12-29These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
63629-3299-22021-12-29These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
63629-3299-32021-12-29These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
63629-3299-12020-01-31These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
63629-3299-22020-01-31These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
63629-3299-32020-01-31These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3299PIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]12Legacy NDC20241108_89fdabe0-dbd5-442a-ae71-c0281e09760c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3299-16362932990130 TABLET in 1 BOTTLE (63629-3299-1) 30 tablet2014-05-120000-00-00NoNoCurrent
63629-3299-26362932990260 TABLET in 1 BOTTLE (63629-3299-2) 60 tablet2014-05-120000-00-00NoNoCurrent
63629-3299-36362932990390 TABLET in 1 BOTTLE (63629-3299-3) 90 tablet2014-05-120000-00-00NoNoCurrent
63629-3299-463629329904180 TABLET in 1 BOTTLE (63629-3299-4) 180 tablet2021-12-280000-00-00NoNoCurrent