Pioglitazone Hydrochloride

Product NDC: 52343-053
11-digit product format: 523430053
Labeler code: 52343
Product ID: 52343-053_62b88c63-8045-4a1e-92b1-4ae0cc6a8354
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pioglitazone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: ACETRIS HEALTH, LLC
Application: ANDA200268
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: 2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52343-053		D	Discontinued by firm	2026-08-07
excluded package	package	52343-053	52343-053-05	D	Discontinued by firm	2026-08-07
excluded package	package	52343-053	52343-053-30	D	Discontinued by firm	2026-08-07
excluded package	package	52343-053	52343-053-90	D	Discontinued by firm	2026-08-07

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 · 48 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	52343-053-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52343-053-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52343-053-05	`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	52343-053-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52343-053-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52343-053-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52343-053-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52343-053-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52343-053-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52343-053-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52343-053-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52343-053-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52343-053-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52343-053-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52343-053-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52343-053-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52343-053-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52343-053-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52343-053-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52343-053-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52343-053-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52343-053-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52343-053-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52343-053-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52343-053-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52343-053-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52343-053-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52343-053-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52343-053-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52343-053-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52343-053-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52343-053-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52343-053-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52343-053-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52343-053-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52343-053-05	`557ba5c1ecfa…`	`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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200268-001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13
A200268-002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13
A200268-003	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
A200268-001	AB
A200268-002	AB
A200268-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	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	A200268-001	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	A200268-002	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	A200268-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200268-003	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	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200268-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200268-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A200268-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200268-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200268-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200268-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200268-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200268-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200268-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200268-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200268-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200268-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200268-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200268-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200268-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200268-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200268-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200268-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200268-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200268-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200268-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200268-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200268-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200268-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200268-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200268-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200268-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200268-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200268-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200268-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200268-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200268-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200268-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200268-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200268-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200268-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200268-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200268-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52343-053-05	EA - Each	52343-053	3587d53a-3dbb-4b9c-9851-a6893cba8984	1	2014-02-04
52343-053-30	EA - Each	52343-053	36494a8c-a032-48ce-a267-21f9c4361a2b	1	2014-02-04
52343-053-90	EA - Each	52343-053	e40ed780-0ffe-4700-8014-183d4977f6e1	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PIOGLITAZONE HYDROCHLORIDE	ACTIVE INGREDIENT	JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1
PIOGLITAZONE	ACTIVE MOIETY	X4OV71U42S	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PIOGLITAZONE HYDROCHLORIDE TABLET [GEN-SOURCE RX]	1

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pioglitazone	PIOGLITAZONE	Major Pharmaceuticals	72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	6cd7c8b7-f5d4-423b-ae9f-86541869d8cf	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Bryant Ranch Prepack	466ef4c8-84d4-4ded-8505-a33f12adf31c	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	e64b46e5-3c94-4635-908e-cdc2263bd3d4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	REMEDYREPACK INC.	3a9f6777-9b4f-482a-aa4e-4900f9d35b8e	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	REMEDYREPACK INC.	55f9b2d8-3e78-4e2f-bcf1-d00595078fa1	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	41a9586c-8768-4fc3-bb78-e6d98b09030b	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	29073b0a-1d7e-4354-87c7-e764106978d8	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	REMEDYREPACK INC.	04577c39-a9c0-4c66-a775-4c79e2c3dea5	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Preferred Pharmaceuticals, Inc.	164c444c-7c56-4482-9cbd-0e0f0ad30c44	2025-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Preferred Pharmaceuticals, Inc.	060e3169-46a7-419d-9acc-05586cb2406b	2025-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Bryant Ranch Prepack	c9548800-4c44-473d-a89b-c705484548b3	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Bryant Ranch Prepack	6397fb4c-081b-4abd-ab4b-0a3fbf99e663	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	Aurobindo Pharma Limited	1f259863-21fd-4d62-b094-4eff845944df	2025-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	QUALLENT PHARMACEUTICALS HEALTH LLC	0331400c-b163-4856-bfb0-965470247cb3	2025-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Rising Pharma Holdings, Inc.	4483b1c6-7095-4a63-8128-ac2d91e11040	2025-05-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
PIOGLITAZONE	PIOGLITAZONE	DIRECT RX	a7e8d5a3-b0da-1d70-e053-2a95a90aa435	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	Bryant Ranch Prepack	f6cad01e-cd65-4c8d-9e49-399404f22005	2024-12-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	NuCare Pharmaceuticals,Inc.	a1112e4b-e9d5-13c3-e053-2995a90a6d0a	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268
Pioglitazone	PIOGLITAZONE	NuCare Pharmaceuticals,Inc.	a0846e3e-68b2-fd55-e053-2995a90a673e	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200268 application number: ANDA200268

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52343-053-05	52343005305	500 TABLET in 1 BOTTLE (52343-053-05)	500 tablet	2013-02-13	0000-00-00	No	No	Current
52343-053-30	52343005330	30 TABLET in 1 BOTTLE (52343-053-30)	30 tablet	2013-02-13	0000-00-00	No	No	Current
52343-053-90	52343005390	90 TABLET in 1 BOTTLE (52343-053-90)	90 tablet	2013-02-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pioglitazone Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2021-03-17	Human Prescription Drug Label	1
Pioglitazone Hydrochloride	ACETRIS HEALTH, LLC \| Aurolife Pharma, LLC \| Aurobindo Pharma Limited	2019-01-14	Human Prescription Drug Label	4