Home NDC 67386-422-01 Xenazine
Product NDC 67386-422
Requested package NDC 67386-422-01
11-digit product format 673860422
Labeler code 67386
Product ID 67386-422_6f524695-2fc1-4c54-9212-69cff22cdfa7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tetrabenazine
Dosage form TABLET
Route ORAL
Labeler Lundbeck Pharmaceuticals LLC
Application NDA021894
Marketing category NDA
Marketing start 2008-11-24
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 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67386-422 67386-422-01 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67386-422 67386-422-01 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
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 N021894-001 XENAZINE TETRABENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 N021894-002 XENAZINE TETRABENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15
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 · 82 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 2026-02-19 14:30 UTC 2026-02 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021894-001 XENAZINE 12.5MG TABLET / ORAL AB RLD 2008-08-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021894-002 XENAZINE 25MG TABLET / ORAL AB RLD, RS 2008-08-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xenazine
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199592 Internal RxNorm lookup 805462 Internal RxNorm lookup 805464 Internal RxNorm lookup 805466 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67386-422-01 Xenazine 112 in 1 BOTTLE TABLET 112 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67386-422 XENAZINE (TETRABENAZINE) TABLET [LUNDBECK PHARMACEUTICALS LLC] 21 Current NDC, Legacy NDC, 1 package rows 20220805_ac768bab-8afa-4446-bc7f-caeeffec0cda.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 · 2 matching rows.
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 67386-422-01 67386042201 112 TABLET in 1 BOTTLE (67386-422-01) 112 tablet 2008-11-24 0000-00-00 No No Current