tetrabenazine

Generic: tetrabenazine

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tetrabenazine
Generic Name tetrabenazine
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

tetrabenazine 12.5 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-821
Product ID 31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204574
Listing Expiration 2026-12-31
Marketing Start 2015-08-17

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 31722821
Hyphenated Format 31722-821

Supplemental Identifiers

RxCUI
199592 805464
UPC
0331722822114
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 ANDA204574 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 112 TABLET, COATED in 1 BOTTLE (31722-821-11)
  • 10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)
  • 100 TABLET, COATED in 1 CARTON (31722-821-32)
  • 56 TABLET, COATED in 1 BOTTLE (31722-821-56)
source: ndc

Packages (4)

31722-821-11 112 TABLET, COATED in 1 BOTTLE (31722-821-11) 31722-821-31 10 TABLET, COATED in 1 BLISTER PACK (31722-821-31) 31722-821-32 100 TABLET, COATED in 1 CARTON (31722-821-32) 31722-821-56 56 TABLET, COATED in 1 BOTTLE (31722-821-56)

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": "3a2ffa8c-f4c5-47e2-8775-5d0edfa55658", "openfda": {"nui": ["N0000190856", "N0000190855"], "upc": ["0331722822114"], "unii": ["Z9O08YRN8O"], "rxcui": ["199592", "805464"], "spl_set_id": ["a03c3cf8-fcd4-4dbf-a4f5-59bd7887c902"], "pharm_class_epc": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]"], "pharm_class_moa": ["Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 TABLET, COATED in 1 BOTTLE (31722-821-11)", "package_ndc": "31722-821-11", "marketing_start_date": "20150817"}, {"sample": false, "description": "10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)", "package_ndc": "31722-821-31", "marketing_start_date": "20150817"}, {"sample": false, "description": "100 TABLET, COATED in 1 CARTON (31722-821-32)", "package_ndc": "31722-821-32", "marketing_start_date": "20150817"}, {"sample": false, "description": "56 TABLET, COATED in 1 BOTTLE (31722-821-56)", "package_ndc": "31722-821-56", "marketing_start_date": "20150817"}], "brand_name": "Tetrabenazine", "product_id": "31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658", "dosage_form": "TABLET, COATED", "pharm_class": ["Vesicular Monoamine Transporter 2 Inhibitor [EPC]", "Vesicular Monoamine Transporter 2 Inhibitors [MoA]"], "product_ndc": "31722-821", "generic_name": "Tetrabenazine", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tetrabenazine", "active_ingredients": [{"name": "TETRABENAZINE", "strength": "12.5 mg/1"}], "application_number": "ANDA204574", "marketing_category": "ANDA", "marketing_start_date": "20150817", "listing_expiration_date": "20261231"}