tetrabenazine

Generic: tetrabenazine

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler oceanside pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 12.5 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-421
Product ID 68682-421_586baf1c-9d44-4772-9736-5073591ed41a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021894
Listing Expiration 2026-12-31
Marketing Start 2015-07-20

Pharmacologic Class

Established (EPC)
vesicular monoamine transporter 2 inhibitor [epc]
Mechanism of Action
vesicular monoamine transporter 2 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682421
Hyphenated Format 68682-421

Supplemental Identifiers

RxCUI
199592 805464
UNII
Z9O08YRN8O
NUI
N0000190856 N0000190855

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tetrabenazine (source: ndc)
Generic Name tetrabenazine (source: ndc)
Application Number NDA021894 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 112 TABLET in 1 BOTTLE (68682-421-12)
source: ndc

Packages (1)

68682-421-12 112 TABLET in 1 BOTTLE (68682-421-12)

Ingredients (1)

tetrabenazine (12.5 mg/1)

Linked Drug Pages (1)

tetrabenazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "586baf1c-9d44-4772-9736-5073591ed41a", "openfda": {"nui": ["N0000190856", "N0000190855"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["5867189c-17bd-4e70-a079-c4730f9950d1"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET in 1 BOTTLE (68682-421-12)", "package_ndc": "68682-421-12", "marketing_start_date": "20150720"}], "brand_name": "tetrabenazine", "product_id": "68682-421_586baf1c-9d44-4772-9736-5073591ed41a", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "68682-421", "generic_name": "tetrabenazine", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "12.5 mg/1"}], "application_number": "NDA021894", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20150720", "listing_expiration_date": "20261231"}