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United States · US · US:0641-6018_ccb9f1b7-b7b1-4db2-b5db-093d147529a7

Dopram

Orange BookUNIISPLATC R07AB01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeR07AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0641601801
    20 mL in 1 VIAL (0641-6018-01)
  • ndc11
    0641601806
    6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01)

Annotations

UNII (FDA Substance ID)
P5RU6UOQ5Y
DOXAPRAM HYDROCHLORIDE
RxCUI 82011
Orange Book
N014879
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P5RU6UOQ5Y",
    "rxcui": "82011",
    "inchikey": "ZOMBFZRWMLIDPX-UHFFFAOYSA-N",
    "display_name": "DOXAPRAM HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "b8eb330a-a75b-46cb-b694-5be9327ed2eb": {
      "match": "brand_token",
      "title": "DOPRAM (DOXAPRAM HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]",
      "spl_version": "6",
      "published_date": "2024-04-10"
    }
  },
  "productid": "0641-6018_ccb9f1b7-b7b1-4db2-b5db-093d147529a7",
  "productndc": "0641-6018",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "014879",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DOXAPRAM HYDROCHLORIDE",
  "proprietary_name": "Dopram",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA014879",
  "marketing_category": "NDA",
  "nonproprietary_name": "Doxapram hydrochloride",
  "start_marketing_date": "19650623",
  "active_numerator_strength": "20"
}

Related drugs

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