Tetrabenazine

Product NDC: 47335-179
11-digit product format: 473350179
Labeler code: 47335
Product ID: 47335-179_86ebe1dd-8c77-4615-8a4c-1e8ec4dc0098
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tetrabenazine
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA206129
Marketing category: ANDA
Marketing start: 2015-08-17
Substance: TETRABENAZINE
Active strength: 25 mg/1
Pharmacologic classes: Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206129-001	TETRABENAZINE	TETRABENAZINE	12.5MG	TABLET / ORAL			2015-08-17
A206129-002	TETRABENAZINE	TETRABENAZINE	25MG	TABLET / ORAL			2015-08-17

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL		2015-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL		2015-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206129-001	TETRABENAZINE	12.5MG	TABLET / ORAL	AB	2015-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206129-002	TETRABENAZINE	25MG	TABLET / ORAL	AB	2015-08-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206129-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206129-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206129-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206129-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206129-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206129-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206129-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206129-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206129-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206129-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206129-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206129-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206129-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206129-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206129-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206129-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206129-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206129-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206129-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206129-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206129-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206129-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206129-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206129-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206129-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206129-002	AB	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A206129-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A206129-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206129-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206129-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206129-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A206129-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206129-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A206129-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206129-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206129-002	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRABENAZINE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Z9O08YRN8O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199592	Internal RxNorm lookup
805464	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
b7d93006-7f06-4da4-985e-6b948c2468e8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dd868135-b25c-abb7-9326-3e7691e6893f	Product name	8	20200611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47335-179-23	Tetrabenazine	112 in 1 BOTTLE	TABLET	112		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-179-23	EA - Each	47335-179	f5264d58-f4ef-4516-b8a7-04ac9276bb93	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRABENAZINE	ACTIVE INGREDIENT	Z9O08YRN8O	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
TETRABENAZINE	ACTIVE MOIETY	Z9O08YRN8O	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	TETRABENAZINE TABLET [SUN PHARMA GLOBAL FZE]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-179	TETRABENAZINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20230907_b7d93006-7f06-4da4-985e-6b948c2468e8.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
Tetrabenazine	TETRABENAZINE	Sun Pharmaceutical Industries, Inc.	b7d93006-7f06-4da4-985e-6b948c2468e8	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206129 application number: ANDA206129 ndc (product): 47335-179

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z9O08YRN8O	TETRABENAZINE	58-46-8	TETRABENAZINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
805464	tetrabenazine 12.5 MG Oral Tablet	PSN	b7d93006-7f06-4da4-985e-6b948c2468e8	10
199592	tetrabenazine 25 MG Oral Tablet	PSN	b7d93006-7f06-4da4-985e-6b948c2468e8	10
805464	tetrabenazine 12.5 MG Oral Tablet	SCD	b7d93006-7f06-4da4-985e-6b948c2468e8	10
199592	tetrabenazine 25 MG Oral Tablet	SCD	b7d93006-7f06-4da4-985e-6b948c2468e8	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-179-23	47335017923	112 TABLET in 1 BOTTLE (47335-179-23)	112 tablet	2015-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tetrabenazine	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2023-09-06	Human Prescription Drug Label	10