pioglitazone

Product NDC: 68382-307
11-digit product format: 683820307
Labeler code: 68382
Product ID: 68382-307_16e816dd-13f7-4e4d-a58a-6d2e6090b0d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pioglitazone
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA202456
Marketing category: ANDA
Marketing start: 2016-11-16
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-307		D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-01	D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-05	D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-06	D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-10	D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-16	D	Discontinued by firm	2026-10-15
excluded package	package	68382-307	68382-307-77	D	Discontinued by firm	2026-10-15

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-307-77	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-307-77	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202456-001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13
A202456-002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13
A202456-003	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202456-001	AB
A202456-002	AB
A202456-003	AB

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202456-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202456-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202456-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A202456-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202456-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202456-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A202456-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202456-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202456-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A202456-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202456-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202456-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A202456-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202456-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202456-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202456-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202456-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202456-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A202456-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202456-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202456-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A202456-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202456-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202456-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202456-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202456-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202456-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202456-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202456-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202456-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202456-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202456-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202456-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202456-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202456-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202456-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A202456-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202456-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202456-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A202456-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202456-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202456-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202456-003	AB	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE
X4OV71U42S	PIOGLITAZONE	111025-46-8	pioglitazone

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-307-01	68382030701	100 TABLET in 1 BOTTLE (68382-307-01)	100 tablet	2016-11-16	0000-00-00	No	No	Current
68382-307-05	68382030705	500 TABLET in 1 BOTTLE (68382-307-05)	500 tablet	2016-11-16	0000-00-00	No	No	Current
68382-307-06	68382030706	30 TABLET in 1 BOTTLE (68382-307-06)	30 tablet	2016-11-16	0000-00-00	No	No	Current
68382-307-10	68382030710	1000 TABLET in 1 BOTTLE (68382-307-10)	1000 tablet	2016-11-16	0000-00-00	No	No	Current
68382-307-16	68382030716	90 TABLET in 1 BOTTLE (68382-307-16)	90 tablet	2016-11-16	0000-00-00	No	No	Current
68382-307-77	68382030777	10 BLISTER PACK in 1 CARTON (68382-307-77) > 10 TABLET in 1 BLISTER PACK (68382-307-30)	10 blister pack	2016-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
pioglitazone	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	7