Home NDC 43598-394 Tetrabenazine
Product NDC 43598-394
11-digit product format 435980394
Labeler code 43598
Product ID 43598-394_b3ddb23f-3cc7-7c18-982b-970f7acc8766
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetrabenazine
Dosage form TABLET
Route ORAL
Labeler Dr. Reddys Laboratories Inc
Application ANDA209284
Marketing category ANDA
Marketing start 2018-01-08
Substance TETRABENAZINE
Active strength 12.5 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 A209284-001 TETRABENAZINE TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 A209284-002 TETRABENAZINE TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08
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 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209284-001 TETRABENAZINE 12.5MG TABLET / ORAL AB 2018-01-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209284-002 TETRABENAZINE 25MG TABLET / ORAL AB 2018-01-08 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 Tetrabenazine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRABENAZINE 12.5 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-394-05 Tetrabenazine 500 in 1 BOTTLE TABLET 500 6 43598-394-67 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 43598-394 TETRABENAZINE TABLET [DR. REDDYS LABORATORIES INC] 6 Current NDC, Legacy NDC, 2 package rows 20211130_ef5f9dd4-945f-ec27-518d-90996a7bd4b6.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.
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 43598-394-05 43598039405 500 TABLET in 1 BOTTLE (43598-394-05) 500 tablet 2018-01-08 0000-00-00 No No Current 43598-394-67 43598039467 112 TABLET in 1 BOTTLE (43598-394-67) 112 tablet 2018-01-08 0000-00-00 No No Current