Home NDC 64764-302 Duetact
Product NDC 64764-302
11-digit product format 647640302
Labeler code 64764
Product ID 64764-302_23f68487-5d22-4618-9ccc-417aeb9fd3a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pioglitazone and glimepiride
Dosage form TABLET
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA021925
Marketing category NDA
Marketing start 2006-07-28
Substance GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength 2; 30 mg/1; 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], Sulfonylurea Compounds [CS], Sulfonylurea [EPC], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N021925-001 DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 N021925-002 DUETACT GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE 4MG;30MG TABLET / ORAL AB RLD 2006-07-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 N021925-001 7700128 2027-01-30 Drug product N021925-001 8071130 2028-06-08 Drug product 2011-12-15 N021925-002 7700128 2027-01-30 Drug product N021925-002 8071130 2028-06-08 Drug product
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 · 82 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 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021925-001 DUETACT 2MG;30MG TABLET / ORAL AB RLD, RS 2006-07-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021925-002 DUETACT 4MG;30MG TABLET / ORAL AB RLD 2006-07-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Patent history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021925-001 7700128 2027-01-30 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021925-002 7700128 2027-01-30 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021925-002 8071130 2028-06-08 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-001 7700128 2027-01-30 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-002 7700128 2027-01-30 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021925-002 8071130 2028-06-08 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021925-001 7700128 2027-01-30 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021925-002 7700128 2027-01-30 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021925-002 8071130 2028-06-08 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-001 7700128 2027-01-30 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-002 7700128 2027-01-30 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021925-002 8071130 2028-06-08 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-001 7700128 2027-01-30 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-002 7700128 2027-01-30 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021925-002 8071130 2028-06-08 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-001 7700128 2027-01-30 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-002 7700128 2027-01-30 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021925-002 8071130 2028-06-08 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-001 7700128 2027-01-30 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-002 7700128 2027-01-30 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021925-002 8071130 2028-06-08 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-001 7700128 2027-01-30 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-002 7700128 2027-01-30 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021925-002 8071130 2028-06-08 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-001 7700128 2027-01-30 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-002 7700128 2027-01-30 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021925-002 8071130 2028-06-08 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021925-001 7700128 2027-01-30 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021925-001 8071130 2028-06-08 Drug product 2011-12-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021925-002 7700128 2027-01-30 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021925-002 8071130 2028-06-08 Drug product d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Duetact
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 2 mg/1 GLIMEPIRIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6KY687524K Internal UNII lookup JQT35NPK6C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 647237 Internal RxNorm lookup 647239 Internal RxNorm lookup 731457 Internal RxNorm lookup 731463 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64764-302-30 Duetact 30 in 1 BOTTLE TABLET 30 23 64764-302-90 Duetact 90 in 1 BOTTLE TABLET 90 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded glimepiride ACTIVE INGREDIENT 6KY687524K DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 pioglitazone hydrochloride ACTIVE INGREDIENT JQT35NPK6C DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 glimepiride ACTIVE MOIETY 6KY687524K DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 pioglitazone ACTIVE MOIETY X4OV71U42S DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 magnesium stearate INACTIVE INGREDIENT 70097M6I30 DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-302 DUETACT (PIOGLITAZONE AND GLIMEPIRIDE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 23 Current NDC, Legacy NDC, 2 package rows 20250409_f8b0c917-3fdd-4a28-a47d-6225b8195458.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64764-302-30 64764030230 30 TABLET in 1 BOTTLE (64764-302-30) 30 tablet 2006-07-28 0000-00-00 No No Current 64764-302-90 64764030290 90 TABLET in 1 BOTTLE (64764-302-90) 90 tablet 2006-07-28 0000-00-00 No No Current