Nymalize

Orange BookUNIISPLATC C08CA06

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

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
2433823012
12 PACKAGE in 1 CARTON (24338-230-12) / 1 SYRINGE, PLASTIC in 1 PACKAGE (24338-230-05) / 5 mL in 1 SYRINGE, PLASTIC
ndc11
2433823030
12 BLISTER PACK in 1 CARTON (24338-230-30) / 1 SYRINGE, PLASTIC in 1 BLISTER PACK (24338-230-15) / 5 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

57WA9QZ5WH

NIMODIPINE

RxCUI 7426

Orange Book

N203340

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": "24338-230_217909ac-1821-85a8-e063-6294a90a9e0c",
  "productndc": "24338-230",
  "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        "strength": "3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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/5mL",
  "application_number": "NDA203340",
  "marketing_category": "NDA",
  "nonproprietary_name": "nimodipine",
  "start_marketing_date": "20200504",
  "active_numerator_strength": "30"
}

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