PIOGLITAZONE HYDROCHLORIDE

Product NDC: 65862-512
Requested package NDC: 65862-512-55
11-digit product format: 658620512
Labeler code: 65862
Product ID: 65862-512_75b48749-1268-4752-8a50-83382f05c951
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pioglitazone hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA200268
Marketing category: ANDA
Marketing start: 2013-02-13
Substance: PIOGLITAZONE HYDROCHLORIDE
Active strength: 15 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

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
unfinished package	package	65862-512	65862-512-55	UNFINISHED	Active or certified unfinished drug listing		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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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 HYDROCHLORIDE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIOGLITAZONE HYDROCHLORIDE	15 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312440	Internal RxNorm lookup
312441	Internal RxNorm lookup
317573	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
1f259863-21fd-4d62-b094-4eff845944df	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-512-05	PIOGLITAZONE HYDROCHLORIDE	500 in 1 BOTTLE	TABLET	500	11
65862-512-10	PIOGLITAZONE HYDROCHLORIDE	10 in 1 BLISTER PACK	TABLET	10	11
65862-512-10	PIOGLITAZONE HYDROCHLORIDE	3 in 1 CARTON	TABLET	3	11
65862-512-30	PIOGLITAZONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	11
65862-512-90	PIOGLITAZONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-512-05	EA - Each	65862-512	59ae3c0b-10f0-4997-b9d9-2e400ec1104f	1	2019-10-07
65862-512-30	EA - Each	65862-512	7d667435-6388-42f0-a139-fb74b2160bbc	1	2013-03-03
65862-512-90	EA - Each	65862-512	1be915b9-428d-428e-8661-1d765f3bf91d	1	2020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PIOGLITAZONE HYDROCHLORIDE	ACTIVE INGREDIENT	JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
PIOGLITAZONE	ACTIVE MOIETY	X4OV71U42S	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-512	PIOGLITAZONE HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED]	11	Current NDC, Legacy NDC, 5 package rows	20250523_1f259863-21fd-4d62-b094-4eff845944df.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 ndc (product): 65862-512
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317573	pioglitazone 15 MG Oral Tablet	PSN	1f259863-21fd-4d62-b094-4eff845944df	11
312440	pioglitazone 30 MG Oral Tablet	PSN	1f259863-21fd-4d62-b094-4eff845944df	11
312441	pioglitazone 45 MG Oral Tablet	PSN	1f259863-21fd-4d62-b094-4eff845944df	11
317573	pioglitazone 15 MG Oral Tablet	SCD	1f259863-21fd-4d62-b094-4eff845944df	11
312440	pioglitazone 30 MG Oral Tablet	SCD	1f259863-21fd-4d62-b094-4eff845944df	11
312441	pioglitazone 45 MG Oral Tablet	SCD	1f259863-21fd-4d62-b094-4eff845944df	11
312441	pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet	SY	1f259863-21fd-4d62-b094-4eff845944df	11
317573	pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	1f259863-21fd-4d62-b094-4eff845944df	11
312440	pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet	SY	1f259863-21fd-4d62-b094-4eff845944df	11
317573	pioglitazone 15 MG Oral Tablet	PSN	6cd7c8b7-f5d4-423b-ae9f-86541869d8cf	5
317573	pioglitazone 15 MG Oral Tablet	SCD	6cd7c8b7-f5d4-423b-ae9f-86541869d8cf	5
317573	pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	6cd7c8b7-f5d4-423b-ae9f-86541869d8cf	5
317573	pioglitazone 15 MG Oral Tablet	PSN	08dc565a-32c8-4009-a37a-922a6a290142	2
317573	pioglitazone 15 MG Oral Tablet	SCD	08dc565a-32c8-4009-a37a-922a6a290142	2
317573	pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	08dc565a-32c8-4009-a37a-922a6a290142	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-512-55	65862051255	15000 TABLET in 1 BAG (65862-512-55)	15000 tablet	13-FEB-13	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PIOGLITAZONE HYDROCHLORIDE	A-S Medication Solutions	2026-03-24	Human Prescription Drug Label	5
PIOGLITAZONE HYDROCHLORIDE	Aurobindo Pharma Limited	2025-05-17	Human Prescription Drug Label	11
PIOGLITAZONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2021-04-27	Human Prescription Drug Label	2