QELBREE

Product NDC: 17772-133
11-digit product format: 177720133
Labeler code: 17772
Product ID: 17772-133_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: 200 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 42.

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 · 102 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-002	QELBREE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211964-003	QELBREE	EQ 200MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD, RS	2021-04-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211964-001	QELBREE	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	RLD	2021-04-02	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 504 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-001	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-002	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	11324753	2029-09-04	U-727		2022-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	11458143	2029-09-04	U-727		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	12121523	2029-09-04	U-727		2024-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9358204	2033-02-07		Drug product	2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9603853	2033-02-07	U-727		2021-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211964-003	9662338	2035-04-02		Drug product	2021-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	11324753	2029-09-04	U-727		2022-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	11458143	2029-09-04	U-727		2022-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	12121523	2029-09-04	U-727		2024-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211964-001	9358204	2033-02-07		Drug product	2021-04-29	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 183 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-001	NCE	2026-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	NPP	2025-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211964-002	NCE	2026-04-02	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: QELBREE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VILOXAZINE HYDROCHLORIDE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
OQW30I1332	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2536548	Internal RxNorm lookup
2536554	Internal RxNorm lookup
2536750	Internal RxNorm lookup
2536752	Internal RxNorm lookup
2536756	Internal RxNorm lookup
2536758	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
aedf408d-0f84-418d-9416-7c39ddb0d29a	Available on FDA.report

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
17772-133-01	QELBREE	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	14
17772-133-07	QELBREE	7 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	7	14
17772-133-30	QELBREE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	14
17772-133-60	QELBREE	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	14
17772-133-90	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
17772-133-07	EA - Each	17772-133	2f23185e-451c-4407-bd63-8baff4550f45	1	2024-05-16
17772-133-30	EA - Each	17772-133	f651e8e7-b71e-4ec6-ae65-e0efc164af87	1	2021-05-05
17772-133-60	EA - Each	17772-133	948a27b8-f597-4b13-8672-0f1e10ad00e6	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17772-133	QELBREE (VILOXAZINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC]	10	Current NDC, Legacy NDC, 5 package rows	20250202_aedf408d-0f84-418d-9416-7c39ddb0d29a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QELBREE	VILOXAZINE HYDROCHLORIDE	Supernus Pharmaceuticals, Inc	aedf408d-0f84-418d-9416-7c39ddb0d29a	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211964 application number: NDA211964 ndc (product): 17772-133

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
17772-133-01	17772013301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-01)	2021-04-02	0000-00-00	No	No	Current
17772-133-07	17772013307	7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-07)	2021-04-02	0000-00-00	Yes	No	Current
17772-133-30	17772013330	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-30)	2021-04-02	0000-00-00	No	No	Current
17772-133-60	17772013360	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-60)	2021-04-02	0000-00-00	No	No	Current
17772-133-90	17772013390	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-133-90)	2021-04-02	0000-00-00	No	No	Current