AUSTEDO XR

Product NDC: 68546-470
11-digit product format: 685460470
Labeler code: 68546
Product ID: 68546-470_56db9945-1fc1-421c-a311-32199bc98890
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deutetrabenazine
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Teva Neuroscience, Inc.
Application: NDA216354
Marketing category: NDA
Marketing start: 2023-02-21
Substance: DEUTETRABENAZINE
Active strength: 6 mg/1
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 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N216354-001	AUSTEDO XR	DEUTETRABENAZINE	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17
N216354-002	AUSTEDO XR	DEUTETRABENAZINE	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17
N216354-003	AUSTEDO XR	DEUTETRABENAZINE	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17
N216354-004	AUSTEDO XR	DEUTETRABENAZINE	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29
N216354-005	AUSTEDO XR	DEUTETRABENAZINE	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29
N216354-006	AUSTEDO XR	DEUTETRABENAZINE	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29
N216354-007	AUSTEDO XR	DEUTETRABENAZINE	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29
N216354-008	AUSTEDO XR	DEUTETRABENAZINE	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01

Orange Book patents#

Current patent rows page 1 of 3 · 240 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216354-001	8524733	2031-04-03		Drug substance, Drug product	2023-02-27
N216354-001	8524733*PED	2031-10-03		Pediatric extension
N216354-001	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27
N216354-001	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27
N216354-001	9550780*PED	2034-03-18		Pediatric extension
N216354-001	10959996	2036-03-07	U-3055		2023-02-27
N216354-001	11357772	2036-03-07	U-1995		2023-02-27
N216354-001	11357772	2036-03-07	U-3055		2023-02-27
N216354-001	11446291	2036-03-07	U-1995		2023-02-27
N216354-001	11564917	2036-03-07	U-1995		2023-02-27
N216354-001	11648244	2036-03-07	U-1995		2023-06-05
N216354-001	12016858	2036-03-07	U-1995		2024-07-25
N216354-001	12016858	2036-03-07	U-3055		2024-07-25
N216354-001	10959996*PED	2036-09-07		Pediatric extension
N216354-001	11357772*PED	2036-09-07		Pediatric extension
N216354-001	11446291*PED	2036-09-07		Pediatric extension
N216354-001	11564917*PED	2036-09-07		Pediatric extension
N216354-001	11648244*PED	2036-09-07		Pediatric extension
N216354-001	12016858*PED	2036-09-07		Pediatric extension
N216354-001	11179386	2038-03-15	U-1995	Drug product	2023-02-27
N216354-001	11179386	2038-03-15	U-3055	Drug product	2023-02-27
N216354-001	11813232	2038-03-15		Drug product	2023-12-07
N216354-001	11179386*PED	2038-09-15		Pediatric extension
N216354-001	11813232*PED	2038-09-15		Pediatric extension
N216354-001	11311488	2041-06-10	U-1995	Drug product	2023-02-27
N216354-001	11311488	2041-06-10	U-3055	Drug product	2023-02-27
N216354-001	12589075	2041-06-10	U-1995		2026-04-29
N216354-001	12589075	2041-06-10	U-3055		2026-04-29
N216354-001	12599598	2041-06-10	U-1995		2026-04-29
N216354-001	12599598	2041-06-10	U-3055		2026-04-29
N216354-002	8524733	2031-04-03		Drug substance, Drug product	2023-02-27
N216354-002	8524733*PED	2031-10-03		Pediatric extension
N216354-002	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27
N216354-002	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27
N216354-002	9550780*PED	2034-03-18		Pediatric extension
N216354-002	10959996	2036-03-07	U-3055		2023-02-27
N216354-002	11357772	2036-03-07	U-1995		2023-02-27
N216354-002	11357772	2036-03-07	U-3055		2023-02-27
N216354-002	11446291	2036-03-07	U-1995		2023-02-27
N216354-002	11564917	2036-03-07	U-1995		2023-02-27
N216354-002	11648244	2036-03-07	U-1995		2023-06-05
N216354-002	12016858	2036-03-07	U-1995		2024-07-25
N216354-002	12016858	2036-03-07	U-3055		2024-07-25
N216354-002	10959996*PED	2036-09-07		Pediatric extension
N216354-002	11357772*PED	2036-09-07		Pediatric extension
N216354-002	11446291*PED	2036-09-07		Pediatric extension
N216354-002	11564917*PED	2036-09-07		Pediatric extension
N216354-002	11648244*PED	2036-09-07		Pediatric extension
N216354-002	12016858*PED	2036-09-07		Pediatric extension
N216354-002	11179386	2038-03-15	U-1995	Drug product	2023-02-27
N216354-002	11179386	2038-03-15	U-3055	Drug product	2023-02-27
N216354-002	11813232	2038-03-15		Drug product	2023-12-07
N216354-002	11179386*PED	2038-09-15		Pediatric extension
N216354-002	11813232*PED	2038-09-15		Pediatric extension
N216354-002	11311488	2041-06-10	U-1995	Drug product	2023-02-27
N216354-002	11311488	2041-06-10	U-3055	Drug product	2023-02-27
N216354-002	12589075	2041-06-10	U-1995		2026-04-29
N216354-002	12589075	2041-06-10	U-3055		2026-04-29
N216354-002	12599598	2041-06-10	U-1995		2026-04-29
N216354-002	12599598	2041-06-10	U-3055		2026-04-29
N216354-003	8524733	2031-04-03		Drug substance, Drug product	2023-02-27
N216354-003	8524733*PED	2031-10-03		Pediatric extension
N216354-003	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27
N216354-003	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27
N216354-003	9550780*PED	2034-03-18		Pediatric extension
N216354-003	10959996	2036-03-07	U-3055		2023-02-27
N216354-003	11357772	2036-03-07	U-1995		2023-02-27
N216354-003	11357772	2036-03-07	U-3055		2023-02-27
N216354-003	11446291	2036-03-07	U-1995		2023-02-27
N216354-003	11564917	2036-03-07	U-1995		2023-02-27
N216354-003	11648244	2036-03-07	U-1995		2023-06-05
N216354-003	12016858	2036-03-07	U-1995		2024-07-25
N216354-003	12016858	2036-03-07	U-3055		2024-07-25
N216354-003	10959996*PED	2036-09-07		Pediatric extension
N216354-003	11357772*PED	2036-09-07		Pediatric extension
N216354-003	11446291*PED	2036-09-07		Pediatric extension
N216354-003	11564917*PED	2036-09-07		Pediatric extension
N216354-003	11648244*PED	2036-09-07		Pediatric extension
N216354-003	12016858*PED	2036-09-07		Pediatric extension
N216354-003	11179386	2038-03-15	U-1995	Drug product	2023-02-27

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 5 · 161 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	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 98 · 3,891 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	N216354-001	8524733	2031-04-03		Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	8524733*PED	2031-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	9550780*PED	2034-03-18		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	10959996	2036-03-07	U-3055		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11357772	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11357772	2036-03-07	U-3055		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11446291	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11564917	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11648244	2036-03-07	U-1995		2023-06-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12016858	2036-03-07	U-1995		2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12016858	2036-03-07	U-3055		2024-07-25	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	10959996*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11357772*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11446291*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11564917*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11648244*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12016858*PED	2036-09-07		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11179386	2038-03-15	U-1995	Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11179386	2038-03-15	U-3055	Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11813232	2038-03-15		Drug product	2023-12-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11179386*PED	2038-09-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11813232*PED	2038-09-15		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11311488	2041-06-10	U-1995	Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	11311488	2041-06-10	U-3055	Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12589075	2041-06-10	U-3055		2026-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12589075	2041-06-10	U-1995		2026-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12599598	2041-06-10	U-3055		2026-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-001	12599598	2041-06-10	U-1995		2026-04-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	8524733	2031-04-03		Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	8524733*PED	2031-10-03		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	9550780*PED	2034-03-18		Pediatric extension		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	10959996	2036-03-07	U-3055		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	11357772	2036-03-07	U-3055		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	11357772	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	11446291	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216354-002	11564917	2036-03-07	U-1995		2023-02-27	`c2088c7a36db…`

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: AUSTEDO XR
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEUTETRABENAZINE	6 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e68dd8a3-5582-4eab-8887-a36647084a78	Product name	2	20250224
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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	Strength	SPL version
68546-470-56	AUSTEDO XR	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68546-470-56	EA - Each	68546-470	c0b6d064-195c-4aec-8c6e-6307c7aee145	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68546-470	AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]	35	Current NDC, 1 package rows	20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P341G6W9NB	DEUTETRABENAZINE	1392826-25-3	DEUTETRABENAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2630160	{14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG]	BPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541519	{14 (deutetrabenazine 12 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 28 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose, 4 Week Titration Pack]	BPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281115	{14 (deutetrabenazine 6 MG Oral Tablet [Austedo]) / 14 (deutetrabenazine 9 MG Oral Tablet [Austedo]) } Pack [Austedo 12 MG Starting Dose Pack]	BPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281117	{21 (deutetrabenazine 6 MG Oral Tablet [Austedo]) } Pack [Austedo 6 MG Starting Dose Pack]	BPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686613	{7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]) } Pack [Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MG]	BPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630159	{14 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 14 (24 HR deutetrabenazine 6 MG Extended Release Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541520	{14 (deutetrabenazine 12 MG Oral Tablet) / 21 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541518	{14 (deutetrabenazine 12 MG Oral Tablet) / 28 (deutetrabenazine 6 MG Oral Tablet) / 28 (deutetrabenazine 9 MG Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281114	{14 (deutetrabenazine 6 MG Oral Tablet) / 14 (deutetrabenazine 9 MG Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281116	{21 (deutetrabenazine 6 MG Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686612	{7 (24 HR deutetrabenazine 12 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 18 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 24 MG Extended Release Oral Tablet) / 7 (24 HR deutetrabenazine 30 MG Extended Release Oral Tablet) } Pack	GPCK	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281117	Austedo (Chorea associated w/Huntington's disease) 6 MG Starting Dose Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876916	Austedo 12 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541519	Austedo 12 MG Starting Dose, 4 Week Titration Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876920	Austedo 6 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876924	Austedo 9 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281115	Austedo Tardive Dyskinesia 12 MG Starting Dose Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630147	Austedo XR 12 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686156	Austedo XR 18 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630153	Austedo XR 24 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683285	Austedo XR 30 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683291	Austedo XR 36 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683297	Austedo XR 42 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683303	Austedo XR 48 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630157	Austedo XR 6 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686613	Austedo XR Once Daily, 4 Week Titration Pack, 12 MG / 18 MG / 24 MG / 30 MG	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630160	Austedo XR Once Daily, 4 Week Titration Pack, 6 MG / 12 MG / 24 MG	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630144	deutetrabenazine 12 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876910	deutetrabenazine 12 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686153	deutetrabenazine 18 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630150	deutetrabenazine 24 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683282	deutetrabenazine 30 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683288	deutetrabenazine 36 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683300	deutetrabenazine 48 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630155	deutetrabenazine 6 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876918	deutetrabenazine 6 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876922	deutetrabenazine 9 MG Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686612	deutetrabenazine once daily pack 12 MG (7), 18 MG (7), 24 MG (7), 30 MG (7) Extended Release Oral Tablet 4 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630159	deutetrabenazine once daily pack 6 MG (14), 12 MG (14), 24 MG (14) Extended Release Oral Tablet 4 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281114	deutetrabenazine starter pack 6 MG (14), 9 MG (14) Oral Tablet 2 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281116	deutetrabenazine starter pack 6 MG (21) Oral Tablet 2 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541520	deutetrabenazine starter pack 6 MG (21), 9 MG (14), 12 MG (14) Oral Tablet 4 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541518	deutetrabenazine starter pack 6 MG (28), 9 MG (28), 12 MG (14) Oral Tablet 4 Week Pack	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683294	deutetrabenazine XR 42 MG 24HR Extended Release Oral Tablet	PSN	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630147	24 HR deutetrabenazine 12 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686156	24 HR deutetrabenazine 18 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630153	24 HR deutetrabenazine 24 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683285	24 HR deutetrabenazine 30 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683291	24 HR deutetrabenazine 36 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683297	24 HR deutetrabenazine 42 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683303	24 HR deutetrabenazine 48 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630157	24 HR deutetrabenazine 6 MG Extended Release Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876916	deutetrabenazine 12 MG Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876920	deutetrabenazine 6 MG Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876924	deutetrabenazine 9 MG Oral Tablet [Austedo]	SBD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630144	24 HR deutetrabenazine 12 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686153	24 HR deutetrabenazine 18 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630150	24 HR deutetrabenazine 24 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683282	24 HR deutetrabenazine 30 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683288	24 HR deutetrabenazine 36 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683294	24 HR deutetrabenazine 42 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683300	24 HR deutetrabenazine 48 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630155	24 HR deutetrabenazine 6 MG Extended Release Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876910	deutetrabenazine 12 MG Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876918	deutetrabenazine 6 MG Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876922	deutetrabenazine 9 MG Oral Tablet	SCD	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2686156	24 HR Austedo 18 MG Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630147	Austedo 12 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876916	Austedo 12 MG Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281115	Austedo 12 MG Starting Dose Pack	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2541519	Austedo 12 MG Starting Dose, 4 Week Titration Pack	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630153	Austedo 24 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683285	Austedo 30 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683291	Austedo 36 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683297	Austedo 42 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2683303	Austedo 48 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2630157	Austedo 6 MG 24 HR Extended Release Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876920	Austedo 6 MG Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
2281117	Austedo 6 MG Starting Dose Pack	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35
1876924	Austedo 9 MG Oral Tablet	SY	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	35

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68546-470-56	68546047056	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56)	2023-02-21	No	No	Current