Home NDC 57237-218 Pioglitazone Hydrochloride and Metformin Hydrochloride
Product NDC 57237-218
11-digit product format 572370218
Labeler code 57237
Product ID 57237-218_e1c4f0ca-4474-4bac-8884-8180e7aec050
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pioglitazone Hydrochloride and Metformin Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA200823
Marketing category ANDA
Marketing start 2013-02-13
Substance PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength 15; 850 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 43 .
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 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13
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 · 86 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 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200823-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200823-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-02-13 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 and Metformin Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 15 mg/1 METFORMIN HYDROCHLORIDE 850 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861783 Internal RxNorm lookup 861822 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 57237-218-60 Pioglitazone Hydrochloride and Metformin Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 11 57237-218-81 Pioglitazone Hydrochloride and Metformin Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-218 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250305_8d252dab-e868-42d3-95ea-69423d909e84.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57237-218-60 57237021860 60 TABLET, FILM COATED in 1 BOTTLE (57237-218-60) 2013-02-13 0000-00-00 No No Current 57237-218-81 57237021881 180 TABLET, FILM COATED in 1 BOTTLE (57237-218-81) 2013-02-13 0000-00-00 No No Current