tetrabenazine

Generic: tetrabenazine

Labeler: dr. reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler dr. reddys laboratories inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

tetrabenazine 12.5 mg/1

Manufacturer
Dr. Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-394
Product ID 43598-394_b3ddb23f-3cc7-7c18-982b-970f7acc8766
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209284
Listing Expiration 2026-12-31
Marketing Start 2018-01-08

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 43598394
Hyphenated Format 43598-394

Supplemental Identifiers

RxCUI
199592 805464
UPC
0343598395678 0343598394671
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 ANDA209284 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (43598-394-05)
  • 112 TABLET in 1 BOTTLE (43598-394-67)
source: ndc

Packages (2)

43598-394-05 500 TABLET in 1 BOTTLE (43598-394-05) 43598-394-67 112 TABLET in 1 BOTTLE (43598-394-67)

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": "b3ddb23f-3cc7-7c18-982b-970f7acc8766", "openfda": {"nui": ["N0000190856", "N0000190855"], "upc": ["0343598395678", "0343598394671"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["ef5f9dd4-945f-ec27-518d-90996a7bd4b6"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Dr. Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (43598-394-05)", "package_ndc": "43598-394-05", "marketing_start_date": "20180108"}, {"sample": false, "description": "112 TABLET in 1 BOTTLE (43598-394-67)", "package_ndc": "43598-394-67", "marketing_start_date": "20180108"}], "brand_name": "Tetrabenazine", "product_id": "43598-394_b3ddb23f-3cc7-7c18-982b-970f7acc8766", "dosage_form": "TABLET", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "43598-394", "generic_name": "Tetrabenazine", "labeler_name": "Dr. Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "12.5 mg/1"}], "application_number": "ANDA209284", "marketing_category": "ANDA", "marketing_start_date": "20180108", "listing_expiration_date": "20261231"}