Pioglitazone

Product NDC: 63304-312
11-digit product format: 633040312
Labeler code: 63304
Product ID: 63304-312_a2a31eaf-b314-445c-a7dd-42a363a04092
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pioglitazone
Dosage form: TABLET
Route: ORAL
Labeler: Ranbaxy Pharmaceuticals Inc.
Application: NDA021073
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-08-17
Marketing end: 0000-00-00
Substance: PIOGLITAZONE HYDROCHLORIDE
Active strength: 30 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: E
Listing certified through: 2018-12-31
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	63304-312		I	Inactivated by FDA	2026-08-07
excluded package	package	63304-312	63304-312-05	I	Inactivated by FDA	2026-08-07
excluded package	package	63304-312	63304-312-30	I	Inactivated by FDA	2026-08-07
excluded package	package	63304-312	63304-312-90	I	Inactivated by FDA	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 2 · 88 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	63304-312-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-312-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63304-312-05	`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	63304-312-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-312-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63304-312-05	`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	63304-312-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-312-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63304-312-05	`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	63304-312-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-312-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63304-312-05	`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	63304-312-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-312-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63304-312-05	`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	63304-312-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-312-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63304-312-05	`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	63304-312-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-312-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63304-312-05	`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	63304-312-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-312-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63304-312-05	`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	63304-312-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-312-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63304-312-05	`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	63304-312-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-312-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63304-312-05	`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	63304-312-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-312-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63304-312-05	`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	63304-312-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-312-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63304-312-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-312-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-312-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	63304-312-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-312-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-312-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63304-312-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-312-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-312-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63304-312-05	`1332a3947898…`	`d4bfe170f9cd…`

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	RLD / RS	Approval date
N021073-001	ACTOS	PIOGLITAZONE HYDROCHLORIDE	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15
N021073-002	ACTOS	PIOGLITAZONE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15
N021073-003	ACTOS	PIOGLITAZONE HYDROCHLORIDE	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021073-001	AB
N021073-002	AB
N021073-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-002	ACTOS	EQ 30MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-003	ACTOS	EQ 45MG BASE	TABLET / ORAL	AB	RLD, RS	1999-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021073-001	ACTOS	EQ 15MG BASE	TABLET / ORAL	AB	RLD	1999-07-15	`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	N021073-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021073-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021073-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021073-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021073-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021073-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021073-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021073-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021073-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021073-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021073-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021073-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021073-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021073-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021073-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021073-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021073-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021073-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021073-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021073-001	AB	1	`8072bd15b7f6…`

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
63304-312-05	2020-01-31	C162847	48780-1	9d75b9d0-bffe-f424-e053-dadaa90a57ce	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
63304-312-30	2020-01-31	C162847	48780-1	9d75b9d0-bffe-f424-e053-dadaa90a57ce	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
63304-312-90	2020-01-31	C162847	48780-1	9d75b9d0-bffe-f424-e053-dadaa90a57ce	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	SPL version
63304-312-05	Pioglitazone	500 in 1 BOTTLE	TABLET	500	2
63304-312-30	Pioglitazone	30 in 1 BOTTLE	TABLET	30	2
63304-312-90	Pioglitazone	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-312-05	EA - Each	63304-312	0922332a-9df0-4075-983d-090dee624602	1	2013-02-13
63304-312-30	EA - Each	63304-312	bfa87cd6-f8da-4ca6-a068-8f677887eda8	1	2013-02-13
63304-312-90	EA - Each	63304-312	69b12d4c-4e97-4da4-a571-867123b0126b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
pioglitazone hydrochloride	ACTIVE INGREDIENT	JQT35NPK6C	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2
pioglitazone	ACTIVE MOIETY	X4OV71U42S	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2
carboxymethylcellulose calcium	INACTIVE INGREDIENT	UTY7PDF93L	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-312	PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]	2	Legacy NDC, 3 package rows	20130112_0478f0e7-87fb-4adb-ae9b-6624555ccbe4.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Actos	PIOGLITAZONE	Takeda Pharmaceuticals America, Inc.	d2ddc491-88a9-4063-9150-443b4fa4330c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021073 application number: NDA021073

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
317573	pioglitazone 15 MG Oral Tablet	PSN	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312440	pioglitazone 30 MG Oral Tablet	PSN	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312441	pioglitazone 45 MG Oral Tablet	PSN	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
317573	pioglitazone 15 MG Oral Tablet	SCD	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312440	pioglitazone 30 MG Oral Tablet	SCD	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312441	pioglitazone 45 MG Oral Tablet	SCD	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312441	pioglitazone (as pioglitazone HCl) 45 MG Oral Tablet	SY	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
317573	pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2
312440	pioglitazone (as pioglitazone hydrochloride) 30 MG Oral Tablet	SY	0478f0e7-87fb-4adb-ae9b-6624555ccbe4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63304-312-05	63304031205	500 in 1 BOTTLE	Historical
63304-312-30	63304031230	30 in 1 BOTTLE	Historical
63304-312-90	63304031290	90 in 1 BOTTLE	Historical