Home NDC 64764-451 Actos
Product NDC 64764-451
11-digit product format 647640451
Labeler code 64764
Product ID 64764-451_20e43dff-4bf2-4ae7-82a1-e7e895123f93
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pioglitazone
Dosage form TABLET
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA021073
Marketing category NDA
Marketing start 1999-07-15
Substance PIOGLITAZONE HYDROCHLORIDE
Active strength 45 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 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.
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.
Additional Listing Data#
Finished product Yes
Brand name base Actos
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 45 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261266 Internal RxNorm lookup 261267 Internal RxNorm lookup 261268 Internal RxNorm lookup 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.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PIOGLITAZONE HYDROCHLORIDE ACTIVE INGREDIENT JQT35NPK6C ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 pioglitazone ACTIVE MOIETY X4OV71U42S ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 carboxymethylcellulose calcium INACTIVE INGREDIENT UTY7PDF93L ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 12 pioglitazone hydrochloride ACTIVE INGREDIENT JQT35NPK6C ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 pioglitazone ACTIVE MOIETY X4OV71U42S ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 carboxymethylcellulose calcium INACTIVE INGREDIENT UTY7PDF93L ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64764-451 ACTOS (PIOGLITAZONE) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] 20 Current NDC, Legacy NDC, 5 package rows 20250409_d2ddc491-88a9-4063-9150-443b4fa4330c.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 ndc (product): 64764-451
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 64764-451-02 64764045102 6 CARTON in 1 TRAY (64764-451-02) / 1 BLISTER PACK in 1 CARTON / 7 TABLET in 1 BLISTER PACK 6 carton 1999-07-15 0000-00-00 No No Current 64764-451-24 64764045124 30 TABLET in 1 BOTTLE (64764-451-24) 30 tablet 1999-07-15 0000-00-00 No No Current 64764-451-25 64764045125 90 TABLET in 1 BOTTLE (64764-451-25) 90 tablet 1999-07-15 0000-00-00 No No Current 64764-451-26 64764045126 500 TABLET in 1 BOTTLE (64764-451-26) 500 tablet 1999-07-15 0000-00-00 No No Current