Home NDC 0781-5627 Pioglitazone and metformin
Product NDC 0781-5627
11-digit product format 007815627
Labeler code 0781
Product ID 0781-5627_b7db37b9-778e-4835-809c-13a65f7e1d8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pioglitazone and metformin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA091273
Marketing category ANDA
Marketing start 2013-05-02
Marketing end 0000-00-00
Substance PIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active strength 15 mg/1; 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],Biguanide [EPC],Biguanides [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16
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 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL 2013-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091273-001 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 500MG;EQ 15MG BASE TABLET / ORAL AB 2013-04-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091273-002 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE 850MG;EQ 15MG BASE TABLET / ORAL AB 2013-04-16 74a2ff9319b5…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METFORMIN HYDROCHLORIDE ACTIVE INGREDIENT 786Z46389E PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 PIOGLITAZONE HYDROCHLORIDE ACTIVE INGREDIENT JQT35NPK6C PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 METFORMIN ACTIVE MOIETY 9100L32L2N PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 PIOGLITAZONE ACTIVE MOIETY X4OV71U42S PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PIOGLITAZONE AND METFORMIN TABLET, FILM COATED [SANDOZ INC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-5627-06 00781562706 5 TABLET, FILM COATED in 1 BLISTER PACK (0781-5627-06) 2013-05-02 0000-00-00 No No Current 0781-5627-60 00781562760 60 TABLET, FILM COATED in 1 BOTTLE (0781-5627-60) 2013-05-02 0000-00-00 No No Current 0781-5627-66 00781562766 20 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-5627-66) 2013-05-02 0000-00-00 No No Current