Home Applications 021842 Application 021842
Type NDA
Sponsor TAKEDA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 500MG;EQ 15MG BASE Yes No 002 ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL 850MG;EQ 15MG BASE Yes Yes
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PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-08-29 N021842-002 ACTOPLUS MET METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG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 Use code 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N021842-001 ACTOPLUS MET 500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2005-08-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021842-002 ACTOPLUS MET 850MG;EQ 15MG BASE TABLET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.
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 Use code 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…
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 ndc (product): 64764-158
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64764-155 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-155 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-155 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-155 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-155 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-158 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-158 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-158 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-158 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current 64764-158 Actoplus Met pioglitazone and metformin hydrochloride Takeda Pharmaceuticals America, Inc. NDA Current