Home NDC 63629-3330 Pioglitazone Hydrochloride
Product NDC 63629-3330
11-digit product format 636293330
Labeler code 63629
Product ID 63629-3330_66717657-3760-463a-be2c-af6be7ed4e16
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pioglitazone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA200044
Marketing category ANDA
Marketing start 2013-02-13
Marketing end 0000-00-00
Substance PIOGLITAZONE HYDROCHLORIDE
Active strength 15 mg/1
Pharmacologic classes 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
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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3330-4 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3330-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3330-2 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3330-5 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-3330-3 D Discontinued by firm d630ba8d3edf…732f749b63fb…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-3330-3 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-3330-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-3330-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63629-3330-4 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-3330-3 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-3330-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-3330-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63629-3330-4 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-3330-3 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-3330-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-3330-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-3330-4 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A200044-001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 A200044-002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 A200044-003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13
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 · 132 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 2026-10-15 13:18:30 2026-09 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 4 · 132 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-3330-1 2022-02-16 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-2 2022-02-16 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-3 2022-02-16 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-4 2022-02-16 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-1 2020-01-31 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-2 2020-01-31 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-3 2020-01-31 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999 63629-3330-4 2020-01-31 These highlights do not include all the information needed to use PIOGLITAZONE TABLETS safely and effectively. See full prescribing information for PIOGLITAZONE TABLETS PIOGLITAZONE tablets, for oral use Initial U.S. Approval: 1999
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-3330 PIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 1010 Legacy NDC 20241109_66717657-3760-463a-be2c-af6be7ed4e16.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-3330-1 63629333001 30 TABLET in 1 BOTTLE (63629-3330-1) 30 tablet 2014-04-28 0000-00-00 No No Current 63629-3330-2 63629333002 90 TABLET in 1 BOTTLE (63629-3330-2) 90 tablet 2014-04-28 0000-00-00 No No Current 63629-3330-3 63629333003 60 TABLET in 1 BOTTLE (63629-3330-3) 60 tablet 2014-06-26 0000-00-00 No No Current 63629-3330-4 63629333004 120 TABLET in 1 BOTTLE (63629-3330-4) 120 tablet 2022-02-08 0000-00-00 No No Current