Tetrabenazine

Orange BookUNIISPLATC N07XX06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDr. Reddys Laboratories Inc

CountryUS (United States)

ATC codeN07XX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4359839405
500 TABLET in 1 BOTTLE (43598-394-05)
ndc11
4359839467
112 TABLET in 1 BOTTLE (43598-394-67)

Annotations

UNII (FDA Substance ID)

Z9O08YRN8O

TETRABENAZINE

RxCUI 10390

Orange Book

A209284

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "Z9O08YRN8O",
    "rxcui": "10390",
    "inchikey": "MKJIEFSOBYUXJB-HOCLYGCPSA-N;MKJIEFSOBYUXJB-GDBMZVCRSA-N",
    "display_name": "TETRABENAZINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "5867189c-17bd-4e70-a079-c4730f9950d1": {
      "match": "brand_token",
      "title": "TETRABENAZINE TABLET [OCEANSIDE PHARMACEUTICALS]",
      "spl_version": "9",
      "published_date": "2026-04-09"
    }
  },
  "productid": "43598-394_b3ddb23f-3cc7-7c18-982b-970f7acc8766",
  "productndc": "43598-394",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209284",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Jan 8, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Jan 8, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRABENAZINE",
  "proprietary_name": "Tetrabenazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209284",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetrabenazine",
  "start_marketing_date": "20180108",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code N07XX06.

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