Pioglitazone

Product NDC: 71335-1659
Requested package NDC: 71335-1659-2
11-digit product format: 713351659
Labeler code: 71335
Product ID: 71335-1659_c2ec028e-5710-4a4d-98b1-c8eef3b90c13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pioglitazone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078670
Marketing category: ANDA
Marketing start: 2013-03-01
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: 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-1659	71335-1659-2	D	Discontinued by firm		2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078670-001	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13
A078670-002	PIOGLITAZONE HYDROCHLORIDE	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13
A078670-003	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
A078670-001	AB
A078670-002	AB
A078670-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078670-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078670-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078670-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078670-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078670-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078670-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	2013-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078670-002	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2013-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078670-003	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	A078670-001	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	A078670-002	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	A078670-003	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	A078670-001	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	2013-02-13	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078670-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078670-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078670-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078670-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078670-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078670-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078670-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078670-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078670-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078670-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078670-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078670-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078670-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078670-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078670-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078670-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078670-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078670-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078670-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078670-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078670-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078670-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078670-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078670-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078670-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078670-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078670-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078670-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078670-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078670-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078670-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078670-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078670-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078670-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078670-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078670-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078670-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078670-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078670-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078670-001	AB	1	`301d65b070ca…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1659	PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]	1	Legacy NDC	20200919_fc5ea675-0eb5-42dd-a33f-46d5fda1517c.zip

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
71335-1659-2	71335165902	90 TABLET in 1 BOTTLE (71335-1659-2)	90 tablet	2020-07-08	0000-00-00	No	No	Current