Actoplus Met

Product NDC: 64764-155
Requested package NDC: 64764-155-60
11-digit product format: 647640155
Labeler code: 64764
Product ID: 64764-155_c19ff52a-9550-409c-9e84-f874f8b49caf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pioglitazone and metformin hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA021842
Marketing category: NDA
Marketing start: 2005-08-29
Marketing end: 0000-00-00
Substance: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength: 500 mg/1; mg/1
Pharmacologic classes: Biguanide [EPC], Biguanides [CS], PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	64764-155	64764-155-60	D	Discontinued by firm		2026-10-05

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 · 12 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 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021842-001	ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29
N021842-002	ACTOPLUS MET	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021842-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N021842-001	9101660	2027-01-22	Drug product	2015-09-10
N021842-001	9320714	2029-02-03	Drug product	2016-05-20
N021842-002	9101660	2027-01-22	Drug product	2015-09-10
N021842-002	9320714	2029-02-03	Drug product	2016-05-20

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE	TABLET / ORAL		RLD	2005-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2005-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2005-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021842-001	ACTOPLUS MET	500MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD	2005-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021842-002	ACTOPLUS MET	850MG;EQ 15MG BASE	TABLET / ORAL	AB	RLD, RS	2005-08-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 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	N021842-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021842-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021842-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021842-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021842-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021842-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021842-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021842-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021842-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021842-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021842-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021842-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021842-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021842-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021842-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021842-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021842-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021842-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021842-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021842-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021842-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021842-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021842-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021842-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021842-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021842-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021842-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021842-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021842-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021842-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021842-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021842-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021842-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021842-001	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-001	9101660	2027-01-22	Drug product	2015-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-001	9320714	2029-02-03	Drug product	2016-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-002	9101660	2027-01-22	Drug product	2015-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021842-002	9320714	2029-02-03	Drug product	2016-05-20	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
e11f0f31-8914-938f-521e-037b6de27c13	Product name	5	20210621
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-155-18	EA - Each	64764-155	c951b8bc-cdfb-469d-8c80-c1a667b910b1	1	2012-07-24
64764-155-60	EA - Each	64764-155	18f92c50-ac88-4a26-b789-1bb106347e22	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METFORMIN HYDROCHLORIDE	ACTIVE INGREDIENT	786Z46389E	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
PIOGLITAZONE HYDROCHLORIDE	ACTIVE INGREDIENT	JQT35NPK6C	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
METFORMIN	ACTIVE MOIETY	9100L32L2N	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
PIOGLITAZONE	ACTIVE MOIETY	X4OV71U42S	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACTOPLUS MET (PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

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
Actoplus Met	PIOGLITAZONE AND METFORMIN HYDROCHLORIDE	Takeda Pharmaceuticals America, Inc.	42e49120-6f3f-11db-9fe1-0800200c9a66	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021842 application number: NDA021842

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861785	actoplus met 15 MG / 500 MG Oral Tablet	PSN	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861824	actoplus met 15 MG / 850 MG Oral Tablet	PSN	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861783	pioglitazone 15 MG / metFORMIN HCl 500 MG Oral Tablet	PSN	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861822	pioglitazone 15 MG / metFORMIN HCl 850 MG Oral Tablet	PSN	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861785	metformin hydrochloride 500 MG / pioglitazone 15 MG Oral Tablet [Actoplus Met]	SBD	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861824	metformin hydrochloride 850 MG / pioglitazone 15 MG Oral Tablet [Actoplus Met]	SBD	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861783	metformin hydrochloride 500 MG / pioglitazone 15 MG Oral Tablet	SCD	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861822	metformin hydrochloride 850 MG / pioglitazone 15 MG Oral Tablet	SCD	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861785	Actoplus Met 15/500 (metformin hydrochloride 500 MG / pioglitazone (as pioglitazone hydrochloride) 15 MG) Oral Tablet	SY	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861785	Actoplus Met 15/500 MG Oral Tablet	SY	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861824	Actoplus Met 15/850 (metformin hydrochloride 850 MG / pioglitazone (as pioglitazone hydrochloride) 15 MG) Oral Tablet	SY	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861824	Actoplus Met 15/850 MG Oral Tablet	SY	f5c534e8-656c-406d-b3dc-b562576ba4eb	2
861822	metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	f5c534e8-656c-406d-b3dc-b562576ba4eb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-155-60	64764015560	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-155-60)	2005-08-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACTOPLUS MET® (pioglitazone hydrochloride and metformin hydrochloride) tablets	Physicians Total Care, Inc.	2010-02-24	HUMAN PRESCRIPTION DRUG LABEL	2