Pioglitazole and metformin hydrochloride

Product NDC: 72162-2498
Requested package NDC: 72162-2498-2
11-digit product format: 721622498
Labeler code: 72162
Product ID: 72162-2498_3531ffd3-afc3-0fdf-e063-6394a90aebcb
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: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Active strength: 850; 15 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 1.

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.

Application-product, TE code table
Application-product	TE code
A204802-001	AB
A204802-002	AB

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204802-001	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	500MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204802-002	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	850MG;EQ 15MG BASE	TABLET / ORAL	AB	2015-11-05	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204802-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204802-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204802-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204802-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204802-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204802-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204802-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204802-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204802-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204802-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204802-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204802-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204802-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204802-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204802-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204802-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204802-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204802-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204802-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204802-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204802-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204802-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204802-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204802-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204802-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204802-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204802-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204802-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204802-002	AB	1	`782e0a99824c…`

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	850 mg/1
METFORMIN HYDROCHLORIDE	15 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
861822	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
bd9c05c9-278f-498d-881c-29ba1b60596e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6a29d87d-f465-752d-5fa9-bd728c608ca2	Product name	4	20251215
f6d21fb1-2c09-48ab-8d89-eeadf5a9698e	Product name	1	20250724
a985afd1-89a8-bfab-0231-b59db1a3a9b5	Product name	7	20250515
25bfaa4d-02a1-402c-96ec-9bf6e625484c	Product name	1	20250307
08b60e13-e5d0-74ca-b5a8-e6df9cb1dca0	Product name	2	20240829
16dbe107-66d5-47b3-57ed-0cba6a8dfccc	Product name	6	20240215
08b3e508-8c7e-3b95-0275-113510642fc6	Product name	2	20220309
e11f0f31-8914-938f-521e-037b6de27c13	Product name	5	20210621
3a90349e-ff2e-41bd-a106-b368fbc1c1f8	Product name	1	20200612
5ab9c07d-ba46-4f19-88f9-a3bc7929fb86	Product name	1	20200214
1dc427fa-8c3b-4309-981e-ea1ff01326e5	Product name	1	20190731
ca3f036c-6c06-b829-b379-1a3a4097099c	Product name	9	20180605
e1ede89f-54c8-428f-ae84-9e8a2deb67db	Product name	1	20180306
5ec207a9-fa56-4ff7-8fae-9a7d9a6bf52c	Product name	2	20170824
bea938a6-c880-985b-d27b-b59b0d8b5a77	Product name	3	20170626
0600b0d3-c32a-40bb-8d87-3a2934cd8f2f	Product name	1	20170616
e2382c7e-9e14-4196-aeff-98e2cfaf63cb	Product name	1	20170224
988f737f-e7e9-4613-8558-824b1ab755f9	Product name	1	20161128
58b66776-50d5-434f-916f-958ccf131e0e	Product name	1	20160713
3e9b6ece-066b-2ac3-28f7-5e13060e5934	Product name	2	20151109
2988466d-5fc4-4430-9cee-fc9132f02d2c	Product name	1	20150910
85cbb42f-1a8d-f945-f85e-188e823b7f5b	Product name	2	20150731
e740bf83-275a-4f0c-adf4-ec60ebd882b7	Product name	1	20150105
8d7b9e2e-c1f8-4f6e-a1f3-e4ce405be5f0	Product name	1	20141205
0d79b284-47e8-e90c-f249-892b9b251003	Product name	1	20140508
25391a6f-d1ba-6bff-d36e-050dc68ef0e6	Product name	1	20140508
2de6e143-c970-2061-1b77-61c3aa8f4026	Product name	1	20140508
2dee091b-3b8c-d27a-b1ba-fcb0d32e776a	Product name	1	20140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8	Product name	1	20140508
ac29cd77-922c-d25a-f8ad-66a8692935c5	Product name	1	20140508
ce63c1f8-ba50-8a17-9290-94522d75daff	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2498-2	Pioglitazole and metformin hydrochloride	180 in 1 BOTTLE	TABLET	180		100
72162-2498-6	Pioglitazole and metformin hydrochloride	60 in 1 BOTTLE	TABLET	60		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2498-2	EA - Each	72162-2498	38be0841-2bfa-4332-8aba-38f9462d4219	1	2025-06-13
72162-2498-6	EA - Each	72162-2498	67450313-1975-4186-811e-2aacee68d0d4	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2498	PIOGLITAZOLE AND METFORMIN HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 2 package rows	20250519_bd9c05c9-278f-498d-881c-29ba1b60596e.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 · 5 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	Macleods Pharmaceuticals Limited	5ff2cd9e-a579-48f5-845f-c37a68372a34	2026-01-03	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	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
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 ndc (package): 72162-2498-2 ndc (product): 72162-2498 ndc11 (package): 72162249802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
786Z46389E	METFORMIN HYDROCHLORIDE	1115-70-4	METFORMIN HYDROCHLORIDE
JQT35NPK6C	PIOGLITAZONE HYDROCHLORIDE	112529-15-4	PIOGLITAZONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861822	pioglitazone 15 MG / metFORMIN HCl 850 MG Oral Tablet	PSN	bd9c05c9-278f-498d-881c-29ba1b60596e	100
861822	metformin hydrochloride 850 MG / pioglitazone 15 MG Oral Tablet	SCD	bd9c05c9-278f-498d-881c-29ba1b60596e	100
861822	metformin HCl 850 mg and pioglitazone (as pioglitazone hydrochloride) 15 MG Oral Tablet	SY	bd9c05c9-278f-498d-881c-29ba1b60596e	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2498-2	72162249802	180 TABLET in 1 BOTTLE (72162-2498-2)	180 tablet	2025-05-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pioglitazole and metformin hydrochloride	Bryant Ranch Prepack	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	100