XELSTRYM

Product NDC: 68968-0210
11-digit product format: 689680210
Labeler code: 68968
Product ID: 68968-0210_5ca2c95c-afcc-91a5-e063-6394a90a6663
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEXTROAMPHETAMINE
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Noven Therapeutics, LLC
Application: NDA215401
Marketing category: NDA
Marketing start: 2023-05-15
Substance: DEXTROAMPHETAMINE
Active strength: 9 mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule: CII
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 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215401-001	XELSTRYM	DEXTROAMPHETAMINE	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-002	XELSTRYM	DEXTROAMPHETAMINE	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-003	XELSTRYM	DEXTROAMPHETAMINE	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22
N215401-004	XELSTRYM	DEXTROAMPHETAMINE	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-001	9474722	2033-10-24		Drug product	2022-04-14
N215401-001	12678504	2034-03-12	U-4583	Drug product	2026-08-10
N215401-001	11559501	2042-01-06		Drug product	2023-02-17
N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-002	9474722	2033-10-24		Drug product	2022-04-14
N215401-002	12678504	2034-03-12	U-4583	Drug product	2026-08-10
N215401-002	11559501	2042-01-06		Drug product	2023-02-17
N215401-003	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-003	9474722	2033-10-24		Drug product	2022-04-14
N215401-003	12678504	2034-03-12	U-4583	Drug product	2026-08-10
N215401-003	11559501	2042-01-06		Drug product	2023-02-17
N215401-004	9456993	2033-10-24	U-3340	Drug product	2022-04-14
N215401-004	9474722	2033-10-24		Drug product	2022-04-14
N215401-004	12678504	2034-03-12	U-4583	Drug product	2026-08-10
N215401-004	11559501	2042-01-06		Drug product	2023-02-17

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 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-001	XELSTRYM	4.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-002	XELSTRYM	9MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-003	XELSTRYM	13.5MG/9HR	SYSTEM / TRANSDERMAL	RLD	2022-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-004	XELSTRYM	18MG/9HR	SYSTEM / TRANSDERMAL	RLD, RS	2022-03-22	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 696 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-001	9474722	2033-10-24		Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-001	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-001	11559501	2042-01-06		Drug product	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-002	9474722	2033-10-24		Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-002	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-002	11559501	2042-01-06		Drug product	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-003	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-003	9474722	2033-10-24		Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-003	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-003	11559501	2042-01-06		Drug product	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-004	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-004	9474722	2033-10-24		Drug product	2022-04-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-004	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N215401-004	11559501	2042-01-06		Drug product	2023-02-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-001	9474722	2033-10-24		Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-001	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-001	11559501	2042-01-06		Drug product	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-002	9474722	2033-10-24		Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-002	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-002	11559501	2042-01-06		Drug product	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-003	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-003	9474722	2033-10-24		Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-003	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-003	11559501	2042-01-06		Drug product	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-004	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-004	9474722	2033-10-24		Drug product	2022-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-004	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215401-004	11559501	2042-01-06		Drug product	2023-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215401-001	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-001	9474722	2033-10-24		Drug product	2022-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-001	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-001	11559501	2042-01-06		Drug product	2023-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-002	9456993	2033-10-24	U-3340	Drug product	2022-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-002	9474722	2033-10-24		Drug product	2022-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-002	12678504	2034-03-12	U-4583	Drug product	2026-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215401-002	11559501	2042-01-06		Drug product	2023-02-17	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-001	NP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-002	NP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-003	NP	2025-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215401-004	NP	2025-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215401-001	NP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-002	NP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-003	NP	2025-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215401-004	NP	2025-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-001	NP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-002	NP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-003	NP	2025-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215401-004	NP	2025-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-001	NP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-002	NP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-003	NP	2025-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215401-004	NP	2025-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-001	NP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-002	NP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-003	NP	2025-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215401-004	NP	2025-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-001	NP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-002	NP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-003	NP	2025-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215401-004	NP	2025-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215401-001	NP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215401-002	NP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215401-003	NP	2025-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215401-004	NP	2025-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215401-001	NP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215401-002	NP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215401-003	NP	2025-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215401-004	NP	2025-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215401-001	NP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215401-002	NP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215401-003	NP	2025-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215401-004	NP	2025-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215401-001	NP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215401-002	NP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215401-003	NP	2025-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215401-004	NP	2025-03-22	`79d66fd596c7…`

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: XELSTRYM
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROAMPHETAMINE	9 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0f66b30d-6b15-4b2d-91a5-1531b9bb6d21	Product name	7	20250625
917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b	Product name	2	20250616
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	5	20230426
8170729e-5ba4-46f9-830f-5f0fae5942ce	Product name	1	20230103
2a7aa275-a4ca-44eb-971f-47427a374085	Product name	9	20220615
aa1b3c66-c4f6-78f2-abd3-31cc9d555e27	Product name	5	20190913
b4c312b9-fad5-247e-cef9-87a74220463d	Product name	4	20171211
ffdf7f68-0f44-4dd6-a026-336dcb345fc4	Product name	1	20151109

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68968-0210-1	XELSTRYM	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1		17
68968-0210-3	XELSTRYM	30 in 1 CARTON	PATCH, EXTENDED RELEASE	30		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68968-0210-1	EA - Each	68968-0210	68b41465-d65d-4286-a33a-b59ced892fff	1	2022-11-07
68968-0210-3	EA - Each	68968-0210	1e1daf6c-b143-4310-a999-76d6ac52c273	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68968-0210	XELSTRYM (DEXTROAMPHETAMINE) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20241222_0862f02a-72a8-41cc-8845-57cf4974bb6f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TZ47U051FI	DEXTROAMPHETAMINE	51-64-9	DEXTROAMPHETAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2624701	dextroamphetamine 13.5 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624712	dextroamphetamine 18 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624726	dextroamphetamine 4.5 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624732	dextroamphetamine 9 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624708	Xelstrym 13.5 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624715	Xelstrym 18 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624729	Xelstrym 4.5 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624735	Xelstrym 9 MG in 9 HR Transdermal System	PSN	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624729	9 HR dextroamphetamine 0.5 MG/HR Transdermal System [Xelstrym]	SBD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624735	9 HR dextroamphetamine 1 MG/HR Transdermal System [Xelstrym]	SBD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624708	9 HR dextroamphetamine 1.5 MG/HR Transdermal System [Xelstrym]	SBD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624715	9 HR dextroamphetamine 2 MG/HR Transdermal System [Xelstrym]	SBD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624726	9 HR dextroamphetamine 0.5 MG/HR Transdermal System	SCD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624732	9 HR dextroamphetamine 1 MG/HR Transdermal System	SCD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624701	9 HR dextroamphetamine 1.5 MG/HR Transdermal System	SCD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624712	9 HR dextroamphetamine 2 MG/HR Transdermal System	SCD	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624729	9 HR Xelstrym 0.5 MG/HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624735	9 HR Xelstrym 1 MG/HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624708	9 HR Xelstrym 1.5 MG/HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624715	9 HR Xelstrym 2 MG/HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624701	dextroamphetamine 13.5 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624712	dextroamphetamine 18 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624726	dextroamphetamine 4.5 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624732	dextroamphetamine 9 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624708	Xelstrym 13.5 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624715	Xelstrym 18 MG in per HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624729	Xelstrym 4.5 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17
2624735	Xelstrym 9 MG per 9 HR Transdermal System	SY	0862f02a-72a8-41cc-8845-57cf4974bb6f	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68968-0210-1	68968021001	1 in 1 POUCH						Historical
68968-0210-3	68968021003	30 POUCH in 1 CARTON (68968-0210-3) / 1 PATCH, EXTENDED RELEASE in 1 POUCH (68968-0210-1)	30 pouch	2023-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
XELSTRYM - Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	Noven Therapeutics, LLC \| Noven Pharmaceuticals, Inc.	2026-10-27	HUMAN PRESCRIPTION DRUG LABEL	18