Home NDC 84677-027 PIOGLITAZONE HYDROCHLORIDE
Product NDC 84677-027
11-digit product format 846770027
Labeler code 84677
Product ID 84677-027_0c6fcd95-9c2f-4d3d-8ec1-730e5d7f38ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PIOGLITAZONE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler GSMS, Incorporated
Application ANDA210165
Marketing category ANDA
Marketing start 2026-06-20
Substance PIOGLITAZONE HYDROCHLORIDE
Active strength 30 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 2027-12-31
Current FDA listing Yes 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 A210165-001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 A210165-002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 A210165-003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22
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 3 · 111 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 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210165-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2021-01-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210165-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2021-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210165-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2021-01-22 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PIOGLITAZONE HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 30 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84677-027-05 84677002705 500 TABLET in 1 BOTTLE (84677-027-05) 500 tablet 2026-06-20 No No Current 84677-027-30 84677002730 30 TABLET in 1 BOTTLE (84677-027-30) 30 tablet 2026-06-20 No No Current 84677-027-90 84677002790 90 TABLET in 1 BOTTLE (84677-027-90) 90 tablet 2026-06-20 No No Current