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United States · US · US:72252-520_a170c6ff-67a0-46be-a207-8fd758c7d103

Valtoco

Orange BookUNIISPLATC N05BA01

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

Identification

ManufacturerNeurelis, Inc
CountryUS (United States)
ATC codeN05BA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7225252004
    2 BLISTER PACK in 1 CARTON (72252-520-04) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    7225252010
    2 BLISTER PACK in 1 CARTON (72252-520-10) / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
Q3JTX2Q7TU
DIAZEPAM
RxCUI 3322
Orange Book
N211635
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Q3JTX2Q7TU",
    "rxcui": "3322",
    "inchikey": "AAOVKJBEBIDNHE-UHFFFAOYSA-N",
    "display_name": "DIAZEPAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "1a8bcc90-68fa-474d-832c-0df01e825f39": {
      "match": "brand_token",
      "title": "VALTOCO (DIAZEPAM) SPRAY [NEURELIS, INC]",
      "spl_version": "14",
      "published_date": "2026-03-23"
    }
  },
  "productid": "72252-520_a170c6ff-67a0-46be-a207-8fd758c7d103",
  "productndc": "72252-520",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "211635",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "7.5MG/SPRAY",
        "product_no": "002",
        "approval_date": "Jan 10, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/SPRAY",
        "product_no": "003",
        "approval_date": "Jan 10, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CIV",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIAZEPAM",
  "proprietary_name": "Valtoco",
  "active_ingred_unit": "mg/.1mL",
  "application_number": "NDA211635",
  "marketing_category": "NDA",
  "nonproprietary_name": "diazepam",
  "start_marketing_date": "20200110",
  "active_numerator_strength": "10"
}

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