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United States · US · US:63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33

Dimenhydrinate

Orange BookUNIISPLATC R06AA11

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeR06AA11
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332336601
    25 VIAL in 1 TRAY (63323-366-01) / 1 mL in 1 VIAL (63323-366-00)

Annotations

UNII (FDA Substance ID)
JB937PER5C
DIMENHYDRINATE
RxCUI 3444
Orange Book
A040519
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "JB937PER5C",
    "rxcui": "3444",
    "inchikey": "NFLLKCVHYJRNRH-UHFFFAOYSA-N",
    "display_name": "DIMENHYDRINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "7c4adbdb-9bce-0c9c-e053-2a91aa0a8107": {
      "match": "brand_token",
      "title": "DIMENHYDRINATE TABLET [LEADER/ CARDINAL HEALTH 110, INC.]",
      "spl_version": "7",
      "published_date": "2026-02-23"
    }
  },
  "productid": "63323-366_b3e3433d-c18b-4ed3-b2ba-1e550474ca33",
  "productndc": "63323-366",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040519",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "50MG/ML",
        "product_no": "001",
        "approval_date": "Jun 23, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIMENHYDRINATE",
  "proprietary_name": "Dimenhydrinate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040519",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dimenhydrinate",
  "start_marketing_date": "20041129",
  "active_numerator_strength": "50"
}

Related drugs

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