Tetrabenazine

Orange BookUNIISPLATC N07XX06

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN07XX06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
3172282111
112 TABLET, COATED in 1 BOTTLE (31722-821-11)
ndc11
3172282131
10 TABLET, COATED in 1 BLISTER PACK (31722-821-31)
ndc11
3172282132
100 TABLET, COATED in 1 CARTON (31722-821-32)
ndc11
3172282156
56 TABLET, COATED in 1 BOTTLE (31722-821-56)

Annotations

UNII (FDA Substance ID)

Z9O08YRN8O

TETRABENAZINE

RxCUI 10390

Orange Book

A204574

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": "31722-821_3a2ffa8c-f4c5-47e2-8775-5d0edfa55658",
  "productndc": "31722-821",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "204574",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12.5MG",
        "product_no": "001",
        "approval_date": "Feb 3, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "25MG",
        "product_no": "002",
        "approval_date": "Feb 3, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRABENAZINE",
  "proprietary_name": "Tetrabenazine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204574",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tetrabenazine",
  "start_marketing_date": "20150817",
  "active_numerator_strength": "12.5"
}

Related drugs

Other records sharing ATC code N07XX06.

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