Home NDC 72189-292 PIOGLITAZONE HYDROCHLORIDE
Product NDC 72189-292
11-digit product format 721890292
Labeler code 72189
Product ID 72189-292_d05f6e91-07a5-658b-e053-2995a90af360
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PIOGLITAZONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler DirectRx
Application ANDA200044
Marketing category ANDA
Marketing start 2021-11-09
Marketing end 0000-00-00
Substance PIOGLITAZONE HYDROCHLORIDE
Active strength 15 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 · 18 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 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72189-292-90 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72189-292-90 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72189-292-90 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72189-292-90 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72189-292-90 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72189-292-90 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72189-292-90 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-292-90 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-292-90 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 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 · 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 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200044-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200044-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200044-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72189-292-90 PIOGLITAZONE HYDROCHLORIDE 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-292 PIOGLITAZONE HYDROCHLORIDE TABLET [DIRECTRX] 1 Legacy NDC, 1 package rows 20211111_d05f6e91-07a4-658b-e053-2995a90af360.zip
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 72189-292-90 72189029290 90 TABLET in 1 BOTTLE (72189-292-90) 90 tablet 2021-11-09 0000-00-00 No No Current