Home NDC 72162-2497 Pioglitazole and metformin hydrochloride
Product NDC 72162-2497
11-digit product format 721622497
Labeler code 72162
Product ID 72162-2497_3531b9e4-c26d-e9a3-e063-6394a90a2c48
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pioglitazole and metformin hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA204802
Marketing category ANDA
Marketing start 2015-11-06
Substance PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength 15; 500 mg/1; mg/1
Pharmacologic classes Biguanide [EPC], Biguanides [CS], 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 88 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 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 c2088c7a36db…2026-10-15 13:18:30 2026-09 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 c2088c7a36db…2026-09-14 22:38:34 2026-08 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204802-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204802-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2015-11-05 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 3 · 88 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 Pioglitazole and metformin hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 15 mg/1 METFORMIN HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JQT35NPK6C Internal UNII lookup 786Z46389E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861783 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72162-2497-2 Pioglitazole and metformin hydrochloride 180 in 1 BOTTLE TABLET 180 100 72162-2497-6 Pioglitazole and metformin hydrochloride 60 in 1 BOTTLE TABLET 60 100
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2497 PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 100 Current NDC, 2 package rows 20250519_7418254e-7232-466f-9d6b-4743b0bba2a1.zip
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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pioglitazone and metformin hydrochloride PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Bryant Ranch Prepack 86ca843a-441b-488d-be1d-2576aeee19cf 2025-12-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204802 application number: ANDA204802 Pioglitazone and metformin hydrochloride PIOGLITAZONE AND METFORMIN HYDROCHLORIDE Bryant Ranch Prepack 8080eedb-e955-4059-98b2-9685b608eb3e 2025-12-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204802 application number: ANDA204802 Pioglitazole and metformin hydrochloride PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE Bryant Ranch Prepack 7418254e-7232-466f-9d6b-4743b0bba2a1 2025-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204802 application number: ANDA204802 ndc (product): 72162-2497 Pioglitazole and metformin hydrochloride PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE Bryant Ranch Prepack bd9c05c9-278f-498d-881c-29ba1b60596e 2025-05-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204802 application number: ANDA204802
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2497-2 72162249702 180 TABLET in 1 BOTTLE (72162-2497-2) 180 tablet 2025-05-15 No No Current 72162-2497-6 72162249706 60 TABLET in 1 BOTTLE (72162-2497-6) 60 tablet 2025-05-15 No No Current