Home NDC 60505-3883 Tetrabenazine
Product NDC 60505-3883
11-digit product format 605053883
Labeler code 60505
Product ID 60505-3883_28a5d355-8681-d49f-0db3-c1da5316e1a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tetrabenazine
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA206093
Marketing category ANDA
Marketing start 2020-06-18
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A206093-001 TETRABENAZINE TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 A206093-002 TETRABENAZINE TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 78 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A206093-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2020-03-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A206093-002 TETRABENAZINE 25MG TABLET / ORAL AB 2020-03-17 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
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 Tetrabenazine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRABENAZINE 25 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-3883-7 Tetrabenazine 112 in 1 BOTTLE TABLET 112 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3883 TETRABENAZINE TABLET [APOTEX CORP.] 5 Current NDC, Legacy NDC, 1 package rows 20241003_471ac1d8-e3ad-7729-87c5-c26ae92c32eb.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 Golden State Medical Supply, Inc. cbfb791e-26ac-9fb5-e053-2995a90ac7e5 2025-10-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 206093 application number: ANDA206093
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-3883-7 60505388307 112 TABLET in 1 BOTTLE (60505-3883-7) 112 tablet 2020-06-18 0000-00-00 No No Current