Home NDC 0904-7090 Pioglitazone
Product NDC 0904-7090
11-digit product format 009047090
Labeler code 0904
Product ID 0904-7090_d6214729-9c39-4bfe-8819-aa818ef5fb69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pioglitazone
Dosage form TABLET
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA200268
Marketing category ANDA
Marketing start 2013-02-13
Substance PIOGLITAZONE HYDROCHLORIDE
Active strength 15 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 A200268-001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 A200268-002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 A200268-003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13
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 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 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200268-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200268-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2013-02-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200268-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2013-02-13 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PIOGLITAZONE HYDROCHLORIDE 15 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312440 Internal RxNorm lookup 317573 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 0904-7090-61 Pioglitazone 100 in 1 CARTON TABLET 100 4 0904-7090-61 Pioglitazone 1 in 1 BLISTER PACK TABLET 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7090 PIOGLITAZONE TABLET [MAJOR PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 2 package rows 20250323_72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f.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 2 of 2 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-7090-61 00904709061 100 BLISTER PACK in 1 CARTON (0904-7090-61) / 1 TABLET in 1 BLISTER PACK 100 blister pack 2013-02-13 0000-00-00 No No Current