Home NDC 0378-0048 Pioglitazone
Product NDC 0378-0048
11-digit product format 003780048
Labeler code 0378
Product ID 0378-0048_0d2ba7ba-5d02-49b8-a2e3-bbfdcbfe9cba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pioglitazone
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA076801
Marketing category ANDA
Marketing start 2012-08-17
Marketing end 2020-01-31
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 0000-00-00
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 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A076801-001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 A076801-002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 A076801-003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17
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 · 129 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 2026-09-14 22:38:34 2026-08 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076801-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL 2012-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076801-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL 2012-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076801-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL 2012-08-17 301d65b070ca…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients#