🇺🇸
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
- ndc11633233660125 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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