Home NDC 42291-806-30 Tetrabenazine
Product NDC 42291-806
Requested package NDC 42291-806-30
11-digit product format 422910806
Labeler code 42291
Product ID 42291-806_d5c9e83d-60d5-fb9c-e053-2995a90a9731
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetrabenazine
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA207682
Marketing category ANDA
Marketing start 2017-02-08
Marketing end 0000-00-00
Substance TETRABENAZINE
Active strength 13 mg/1
Pharmacologic classes Vesicular Monoamine Transporter 2 Inhibitor [EPC], Vesicular Monoamine Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A207682-001 TETRABENAZINE TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 A207682-002 TETRABENAZINE TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207682-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2017-01-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207682-002 TETRABENAZINE 25MG TABLET / ORAL AB 2017-01-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42291-806-30 42291080630 30 TABLET in 1 BOTTLE (42291-806-30) 30 tablet 2017-02-08 0000-00-00 No No Current