Fenofibrate

Manufacturer: Northwind Pharmaceuticals
Effective date: 2014-05-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:18:44

Label at a glance#

ProductFenofibrate

Active ingredientFENOFIBRATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-010-52

MFG: 0093-2060-98

Fenofibrate 145mg

30 Tablets

Rx only

Lot# NW89520001

Exp Date: 06/2016

Each tablet contains: 145mg of fenofibrate

Dosage: See package insert

Store at 77 degrees F. Protect from moisture.

Store in a tight, light-resistant container (See USP) Keep out of reach of children.

Mfg by: Fournier Laboratories Ireland Limited Anngrove, Carrigtwohill Co. Cork, Ireland

Mfg for: Teva Pharmaceuticals USA Sellersville, PA 18960 Lot: 1007225

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Fenofibrate 51655-010

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-010-52	2026-01-10	C162847	48780-1	9d75b9d0-d369-f424-e053-dadaa90a57ce	dbc61583-082b-4e69-8147-0de0ae72016f
51655-010-52	2020-01-31	C162847	48780-1	9d75b9d0-d369-f424-e053-dadaa90a57ce	dbc61583-082b-4e69-8147-0de0ae72016f

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-010	FENOFIBRATE TABLET [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140520_dbc61583-082b-4e69-8147-0de0ae72016f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51655-010-52	EA - Each	51655-010	1007d8e0-a55e-4b65-9b47-2887c91ce262	1	2015-07-20
0093-2060-98	EA - Each	0093-2060	4b2e9e7a-b497-44e8-a4e2-8c2e84a41c95	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	1
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Fenofibrate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51655-010	51655-010-52
0093-2060

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FENOFIBRATE	U202363UOS	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
N021656-001	TRICOR	FENOFIBRATE	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05
N021656-002	TRICOR	FENOFIBRATE	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05

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	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021656-001	TRICOR	48MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021656-002	TRICOR	145MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2004-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021656-001	TRICOR	48MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021656-002	TRICOR	145MG	TABLET / ORAL		RLD	2004-11-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	TRICOR	48MG	TABLET / ORAL	AB	RLD	2004-11-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	TRICOR	145MG	TABLET / ORAL	AB	RLD, RS	2004-11-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021656-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021656-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021656-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021656-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021656-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021656-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021656-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021656-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021656-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021656-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021656-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021656-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021656-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021656-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021656-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021656-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021656-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021656-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021656-002	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-001	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7276249	2023-02-21		Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021656-002	7320802	2023-02-21	U-847		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-001	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7276249	2023-02-21		Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021656-002	7320802	2023-02-21	U-847		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-001	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7276249	2023-02-21		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021656-002	7320802	2023-02-21	U-847		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-001	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7276249	2023-02-21		Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021656-002	7320802	2023-02-21	U-847		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-001	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7276249	2023-02-21		Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021656-002	7320802	2023-02-21	U-847		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-001	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7276249	2023-02-21		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021656-002	7320802	2023-02-21	U-847		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-001	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7276249	2023-02-21		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021656-002	7320802	2023-02-21	U-847		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021656-001	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-001	7320802	2023-02-21	U-847		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	6375986	2020-09-21	U-615	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7276249	2023-02-21		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021656-002	7320802	2023-02-21	U-847		`8869cabd3fbd…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
47bbcf31-0fb2-2751-e063-6294a90abfd3			dbc61583-082b-4e69-8147-0de0ae72016f	2026-01-06		Exact identifier spl set id: dbc61583-082b-4e69-8147-0de0ae72016f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.