QELBREE

Product NDC: 17772-131
11-digit product format: 177720131
Labeler code: 17772
Product ID: 17772-131_453c9f61-1902-44ab-e063-6394a90ab639
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: viloxazine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Supernus Pharmaceuticals, Inc
Application: NDA211964
Marketing category: NDA
Marketing start: 2021-04-02
Substance: VILOXAZINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Norepinephrine Reuptake Inhibitor [EPC], Norepinephrine Uptake Inhibitors [MoA]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211964-001	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02
N211964-002	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02
N211964-003	QELBREE	VILOXAZINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211964-001	11324753	2029-09-04	U-727		2022-05-17
N211964-001	11458143	2029-09-04	U-727		2022-10-07
N211964-001	12121523	2029-09-04	U-727		2024-11-21
N211964-001	9358204	2033-02-07		Drug product	2021-04-29
N211964-001	9603853	2033-02-07	U-727		2021-04-29
N211964-001	9662338	2035-04-02		Drug product	2021-04-29
N211964-002	11324753	2029-09-04	U-727		2022-05-17
N211964-002	11458143	2029-09-04	U-727		2022-10-07
N211964-002	12121523	2029-09-04	U-727		2024-11-21
N211964-002	9358204	2033-02-07		Drug product	2021-04-29
N211964-002	9603853	2033-02-07	U-727		2021-04-29
N211964-002	9662338	2035-04-02		Drug product	2021-04-29
N211964-003	11324753	2029-09-04	U-727		2022-05-17
N211964-003	11458143	2029-09-04	U-727		2022-10-07
N211964-003	12121523	2029-09-04	U-727		2024-11-21
N211964-003	9358204	2033-02-07		Drug product	2021-04-29
N211964-003	9603853	2033-02-07	U-727		2021-04-29
N211964-003	9662338	2035-04-02		Drug product	2021-04-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211964-001	NCE	2026-04-02
N211964-002	NCE	2026-04-02
N211964-003	NCE	2026-04-02

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 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 522 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 186 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N211964-001	NCE	2026-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-002	NCE	2026-04-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211964-003	NCE	2026-04-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211964-001	NCE	2026-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-002	NCE	2026-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211964-003	NCE	2026-04-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211964-001	NCE	2026-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	NCE	2026-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	NCE	2026-04-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	NCE	2026-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-002	NCE	2026-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	NPP	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-003	NCE	2026-04-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211964-001	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-001	NCE	2026-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-002	NCE	2026-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	NPP	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211964-003	NCE	2026-04-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-001	NCE	2026-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-002	NCE	2026-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	NPP	2025-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211964-003	NCE	2026-04-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-001	NCE	2026-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-002	NCE	2026-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	NPP	2025-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211964-003	NCE	2026-04-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-001	NCE	2026-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-002	NCE	2026-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	NPP	2025-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211964-003	NCE	2026-04-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	NPP	2025-04-29	`2680178bc6a6…`

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: QELBREE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VILOXAZINE HYDROCHLORIDE	100 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
261a6cfe-eb5e-41f0-a9c1-4bf839598163	Product name	1	20210928
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17772-131-01	QELBREE	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	14
17772-131-07	QELBREE	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	14
17772-131-30	QELBREE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	14
17772-131-60	QELBREE	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	14
17772-131-90	QELBREE	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17772-131-07	EA - Each	17772-131	672429b6-3406-474a-9c3f-f195e82d3d48	1	2024-05-16
17772-131-30	EA - Each	17772-131	abedc5b5-42b1-40a6-96a6-3f863d411684	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17772-131	QELBREE (VILOXAZINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC]	10	Current NDC, Legacy NDC, 5 package rows	20250202_aedf408d-0f84-418d-9416-7c39ddb0d29a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OQW30I1332	VILOXAZINE HYDROCHLORIDE	35604-67-2	VILOXAZINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2536750	24HR viloxazine 150 MG Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536756	24HR viloxazine 200 MG Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536554	Qelbree 100 MG 24HR Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536752	Qelbree 150 MG 24HR Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536758	Qelbree 200 MG 24HR Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536548	viloxazine 100 MG 24HR Extended Release Oral Capsule	PSN	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536554	24 HR viloxazine 100 MG Extended Release Oral Capsule [Qelbree]	SBD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536752	24 HR viloxazine 150 MG Extended Release Oral Capsule [Qelbree]	SBD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536758	24 HR viloxazine 200 MG Extended Release Oral Capsule [Qelbree]	SBD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536548	24 HR viloxazine 100 MG Extended Release Oral Capsule	SCD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536750	24 HR viloxazine 150 MG Extended Release Oral Capsule	SCD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536756	24 HR viloxazine 200 MG Extended Release Oral Capsule	SCD	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536554	24 HR Qelbree 100 MG Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536752	24 HR Qelbree 150 MG Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536758	24 HR Qelbree 200 MG Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536554	Qelbree 100 MG 24 HR Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536752	Qelbree 150 MG 24 HR Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536758	Qelbree 200 MG 24 HR Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14
2536548	viloxazine 100 MG (as viloxazine HCl 115 MG) 24 HR Extended Release Oral Capsule	SY	aedf408d-0f84-418d-9416-7c39ddb0d29a	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17772-131-01	17772013101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-01)	2021-04-02	0000-00-00	No	No	Current
17772-131-07	17772013107	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-07)	2021-04-02	0000-00-00	Yes	No	Current
17772-131-30	17772013130	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-30)	2021-04-02	0000-00-00	No	No	Current
17772-131-60	17772013160	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-60)	2021-04-02	0000-00-00	No	No	Current
17772-131-90	17772013190	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-131-90)	2021-04-02	0000-00-00	No	No	Current