AUSTEDO XR

Product NDC: 68546-477
Requested package NDC: 68546-477-28
11-digit product format: 685460477
Labeler code: 68546
Product ID: 68546-477_69071a25-792d-4eec-a12a-1bb30c8fc881
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deutetrabenazine
Dosage form: KIT
Labeler: Teva Neuroscience, Inc.
Application: NDA216354
Marketing category: NDA
Marketing start: 2024-07-01
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 1.

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 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2025-08-23 18:47 UTC	2025-08	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2024-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-02-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-001	AUSTEDO XR	6MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-002	AUSTEDO XR	12MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2023-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-003	AUSTEDO XR	24MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2023-02-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-004	AUSTEDO XR	30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-005	AUSTEDO XR	36MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-006	AUSTEDO XR	42MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-007	AUSTEDO XR	48MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216354-008	AUSTEDO XR	18MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2024-07-01	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 80 · 3,171 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216354-001	8524733	2031-04-03		Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	8524733*PED	2031-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	9550780*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	10959996	2036-03-07	U-3055		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11357772	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11357772	2036-03-07	U-3055		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11446291	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11564917	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11648244	2036-03-07	U-1995		2023-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	12016858	2036-03-07	U-1995		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	12016858	2036-03-07	U-3055		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	10959996*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11357772*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11446291*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11564917*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11648244*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	12016858*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11179386	2038-03-15	U-1995	Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11179386	2038-03-15	U-3055	Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11813232	2038-03-15		Drug product	2023-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11179386*PED	2038-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11813232*PED	2038-09-15		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11311488	2041-06-10	U-1995	Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-001	11311488	2041-06-10	U-3055	Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	8524733	2031-04-03		Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	8524733*PED	2031-10-03		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	9550780	2033-09-18	U-3055	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	9550780	2033-09-18	U-1995	Drug substance, Drug product	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	9550780*PED	2034-03-18		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	10959996	2036-03-07	U-3055		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	11357772	2036-03-07	U-3055		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	11357772	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	11446291	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	11564917	2036-03-07	U-1995		2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	11648244	2036-03-07	U-1995		2023-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	12016858	2036-03-07	U-3055		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	12016858	2036-03-07	U-1995		2024-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216354-002	10959996*PED	2036-09-07		Pediatric extension		`011fe1cb6892…`

Additional Listing Data#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P341G6W9NB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 33 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1876910	Internal RxNorm lookup
1876916	Internal RxNorm lookup
1876918	Internal RxNorm lookup
1876920	Internal RxNorm lookup
1876922	Internal RxNorm lookup
1876924	Internal RxNorm lookup
2281114	Internal RxNorm lookup
2281115	Internal RxNorm lookup
2281116	Internal RxNorm lookup
2281117	Internal RxNorm lookup
2541518	Internal RxNorm lookup
2541519	Internal RxNorm lookup
2541520	Internal RxNorm lookup
2630144	Internal RxNorm lookup
2630147	Internal RxNorm lookup
2630150	Internal RxNorm lookup
2630153	Internal RxNorm lookup
2630155	Internal RxNorm lookup
2630157	Internal RxNorm lookup
2630159	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
7ea3c60a-45c7-44cc-afc2-d87fa53993c0	Available on FDA.report

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
68546-190-07	AUSTEDO XR	7 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	7	12 mg	35
68546-191-07	AUSTEDO XR	7 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	7	18 mg	35
68546-192-07	AUSTEDO XR	7 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	7	24 mg	35
68546-193-07	AUSTEDO XR	7 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	7	30 mg	35
68546-477-28	AUSTEDO XR	1 in 1 BLISTER PACK	KIT	1		35
68546-477-29	AUSTEDO XR	1 in 1 BLISTER PACK	KIT	1		35
68546-477-29	AUSTEDO XR	1 in 1 CARTON	KIT	1		35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68546-477-29	EA - Each	68546-477	e688bea8-8e7c-4088-b612-7dadec5c03b1	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68546-477	AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.]	35	Current NDC, 7 package rows	20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.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
Austedo	DEUTETRABENAZINE	Teva Neuroscience, Inc.	7ea3c60a-45c7-44cc-afc2-d87fa53993c0	2025-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216354 application number: NDA216354 ndc (package): 68546-477-28 ndc (product): 68546-477 ndc11 (package): 68546047728

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	Units	Marketing start	Sample	Exclude flag	Status
68546-477-28	68546047728	1 KIT in 1 BLISTER PACK (68546-477-28) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-192-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-190-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-193-07) * 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68546-191-07)	1 kit	2024-07-01	Yes	No	Current