CREXONT

Orange BookUNIISPLATC N04BA

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN04BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6489696816
1 BOTTLE in 1 CARTON (64896-968-16) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
ndc11
6489696823
1 BOTTLE in 1 CARTON (64896-968-23) / 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

MNX7R8C5VO

CARBIDOPA HYDRATE

RxCUI 2019

Orange Book

N217186

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MNX7R8C5VO",
    "rxcui": "2019",
    "inchikey": "QTAOMKOIBXZKND-PPHPATTJSA-N",
    "display_name": "CARBIDOPA HYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "095a08b6-b0b8-4f88-b759-67e8b87287a0": {
      "match": "brand_token",
      "title": "CREXONT (CARBIDOPA AND LEVODOPA) CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "19",
      "published_date": "2026-06-01"
    }
  },
  "productid": "64896-968_61f8ee81-fe48-4f07-8c6b-aad4701c7f8b",
  "productndc": "64896-968",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "217186",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "35MG;140MG",
        "product_no": "001",
        "approval_date": "Aug 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "52.5MG;210MG",
        "product_no": "002",
        "approval_date": "Aug 7, 2024"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "70MG;280MG",
        "product_no": "003",
        "approval_date": "Aug 7, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "87.5MG;350MG",
        "product_no": "004",
        "approval_date": "Aug 7, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CARBIDOPA HYDRATE; LEVODOPA",
  "proprietary_name": "CREXONT",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA217186",
  "marketing_category": "NDA",
  "nonproprietary_name": "carbidopa and levodopa",
  "start_marketing_date": "20240809",
  "active_numerator_strength": "52.5; 210"
}

Related drugs

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