Pioglitazone Hydrochloride

Product NDC
72606-571
Requested package NDC
72606-571-03
11-digit product format
726060571
Labeler code
72606
Product ID
72606-571_7d46fdfa-22fd-4711-a7b1-bb0aab912357
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
CELLTRION USA, INC.
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
2021-12-31
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 packagepackage72606-57172606-571-03DDiscontinued 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
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…

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
72606-571-01EA - Each72606-571308934e8-5442-40e0-b793-c2c07702da7212021-03-02
72606-571-02EA - Each72606-5713f97b02b-28c4-4628-8e9b-d5585872567512021-03-02
72606-571-03EA - Each72606-571b26208d8-cd8c-40f6-9ad4-eaa51ed5b48012021-03-02

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSN5462fc93-f6b4-40f8-ade2-5c28b9bde79a101
312440pioglitazone 30 MG Oral TabletSCD5462fc93-f6b4-40f8-ade2-5c28b9bde79a101
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY5462fc93-f6b4-40f8-ade2-5c28b9bde79a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72606-571-0372606057103500 TABLET in 1 BOTTLE (72606-571-03) 500 tablet2020-10-280000-00-00NoNoCurrent