Spravato

Orange BookUNIISPLATC N06AX27

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

Identification

ManufacturerJanssen Pharmaceuticals Inc.

CountryUS (United States)

ATC codeN06AX27

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5045802802
2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)
ndc11
5045802803
3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)

Annotations

UNII (FDA Substance ID)

L8P1H35P2Z

ESKETAMINE HYDROCHLORIDE

RxCUI 2119366

Orange Book

N211243

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L8P1H35P2Z",
    "rxcui": "2119366",
    "inchikey": "VCMGMSHEPQENPE-ZOWNYOTGSA-N",
    "display_name": "ESKETAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "d81a6a79-a74a-44b7-822c-0dfa3036eaed": {
      "match": "brand_token",
      "title": "SPRAVATO (ESKETAMINE HYDROCHLORIDE) SOLUTION [JANSSEN PHARMACEUTICALS INC.]",
      "spl_version": "18",
      "published_date": "2026-03-20"
    }
  },
  "productid": "50458-028_edb747c7-957a-47fa-b5b2-51a25b31c083",
  "productndc": "50458-028",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "211243",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 28MG BASE",
        "product_no": "001",
        "approval_date": "Mar 5, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESKETAMINE HYDROCHLORIDE",
  "proprietary_name": "Spravato",
  "active_ingred_unit": "mg/.2mL",
  "application_number": "NDA211243",
  "marketing_category": "NDA",
  "nonproprietary_name": "Esketamine Hydrochloride",
  "start_marketing_date": "20190305",
  "active_numerator_strength": "28"
}

Related drugs

Other records sharing ATC code N06AX27.

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