Pioglitazone

Product NDC: 68071-5210
Requested package NDC: 68071-5210-1
11-digit product format: 680715210
Labeler code: 68071
Product ID: 68071-5210_1b571858-340c-fc19-e063-6394a90a80c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pioglitazone
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA200268
Marketing category: ANDA
Marketing start: 2013-02-13
Substance: PIOGLITAZONE HYDROCHLORIDE
Active strength: 30 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-5210	68071-5210-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-5210	68071-5210-1	I	Inactivated by FDA		excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pioglitazone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIOGLITAZONE HYDROCHLORIDE	30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JQT35NPK6C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312440	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a1112e4b-e9d5-13c3-e053-2995a90a6d0a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e11f0f31-8914-938f-521e-037b6de27c13	Product name	5	20210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5210-1	2022-07-19	C162847	48780-1	d6a99b39-87e2-a426-e053-dadaa90af4c2	These 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
68071-5210-1	2022-01-28	C162847	48780-1	d6a99b39-87e2-a426-e053-dadaa90af4c2	These 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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5210-1	Pioglitazone	120 in 1 BOTTLE	TABLET	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5210	PIOGLITAZONE TABLET [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240622_a1112e4b-e9d5-13c3-e053-2995a90a6d0a.zip

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 ndc (package): 68071-5210-1 ndc (product): 68071-5210 ndc11 (package): 68071521001
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
X4OV71U42S	PIOGLITAZONE	111025-46-8	Pioglitazone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312440	pioglitazone 30 MG Oral Tablet	PSN	a1112e4b-e9d5-13c3-e053-2995a90a6d0a	3
312440	pioglitazone 30 MG Oral Tablet	SCD	a1112e4b-e9d5-13c3-e053-2995a90a6d0a	3
312440	pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet	SY	a1112e4b-e9d5-13c3-e053-2995a90a6d0a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5210-1	68071521001	120 TABLET in 1 BOTTLE (68071-5210-1)	120 tablet	2020-03-17	0000-00-00	No	No	Current