Home NDC 68071-1621-3 Pioglitazone
Product NDC 68071-1621
Requested package NDC 68071-1621-3
11-digit product format 680711621
Labeler code 68071
Product ID 68071-1621_bb11f412-7d6c-2b4d-e053-2995a90abb56
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pioglitazone
Dosage form TABLET
Route ORAL
Labeler NuCare 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 No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-1621-3 68071162103 30 TABLET in 1 BOTTLE (68071-1621-3) 30 tablet 2017-08-08 0000-00-00 No No Current