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United States · US · US:24338-260_217909ac-1821-85a8-e063-6294a90a9e0c

Nymalize

Orange BookUNIISPLATC C08CA06

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

Identification

ManufacturerAzurity Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeC08CA06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2433826008
    237 mL in 1 BOTTLE (24338-260-08)
  • ndc11
    2433826012
    12 PACKAGE in 1 CARTON (24338-260-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-260-10) / 10 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)
57WA9QZ5WH
NIMODIPINE
RxCUI 7426
Orange Book
N203340
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "57WA9QZ5WH",
    "rxcui": "7426",
    "inchikey": "UIAGMCDKSXEBJQ-UHFFFAOYSA-N",
    "display_name": "NIMODIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "e660fa26-b5c4-4d6d-8887-9e22b6666a10": {
      "match": "brand_token",
      "title": "NYMALIZE (NIMODIPINE) SOLUTION [AZURITY PHARMACEUTICALS, INC.]",
      "spl_version": "9",
      "published_date": "2024-09-09"
    }
  },
  "productid": "24338-260_217909ac-1821-85a8-e063-6294a90a9e0c",
  "productndc": "24338-260",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "203340",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 10, 2013"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "6MG/ML",
        "product_no": "002",
        "approval_date": "Apr 8, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NIMODIPINE",
  "proprietary_name": "Nymalize",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA203340",
  "marketing_category": "NDA",
  "nonproprietary_name": "nimodipine",
  "start_marketing_date": "20200504",
  "active_numerator_strength": "60"
}

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