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United States · US · US:71308-021_43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6

OLINVYK

Orange BookUNIISPLATC N02AX07

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerTrevena, Inc.
CountryUS (United States)
ATC codeN02AX07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7130802110
    10 VIAL, SINGLE-DOSE in 1 CARTON (71308-021-10) / 2 mL in 1 VIAL, SINGLE-DOSE (71308-021-01)

Annotations

UNII (FDA Substance ID)
MCN858TCP0
OLICERIDINE
RxCUI 2392230
Orange Book
N210730
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MCN858TCP0",
    "rxcui": "2392230",
    "inchikey": "DMNOVGJWPASQDL-OAQYLSRUSA-N",
    "display_name": "OLICERIDINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ce167984-8b9d-40b7-84ce-d0f33fff1eaa": {
      "match": "brand_token",
      "title": "OLINVYK (OLICERIDINE) INJECTION, SOLUTION [TREVENA, INC.]",
      "spl_version": "11",
      "published_date": "2026-01-05"
    }
  },
  "productid": "71308-021_43ecba1a-fa95-40e0-a383-8f9cdb6ad6b6",
  "productndc": "71308-021",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210730",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG/ML (1MG/ML)",
        "product_no": "001",
        "approval_date": "Oct 30, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG/2ML (1MG/ML)",
        "product_no": "002",
        "approval_date": "Oct 30, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG/30ML (1MG/ML)",
        "product_no": "003",
        "approval_date": "Oct 30, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OLICERIDINE",
  "proprietary_name": "OLINVYK",
  "active_ingred_unit": "mg/2mL",
  "application_number": "NDA210730",
  "marketing_category": "NDA",
  "nonproprietary_name": "OLICERIDINE",
  "start_marketing_date": "20200807",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code N02AX07.

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