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United States · US · US:0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4
Hydroxyzine
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHenry Schein, Inc.
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1104049878021 VIAL, SINGLE-DOSE in 1 BAG (0404-9878-02) / 2 mL in 1 VIAL, SINGLE-DOSE
Annotations
Orange Book
A087408
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAMUSCULAR",
"spl_meta": {
"4cd84205-6a33-db48-e063-6394a90a9182": {
"match": "brand_token",
"title": "HYDROXYZINE HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "0404-9878_5d9b6c38-5a58-4278-999a-f430f34aafd4",
"productndc": "0404-9878",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "087408",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "25MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "50MG/ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "HYDROXYZINE DIHYDROCHLORIDE",
"proprietary_name": "Hydroxyzine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA087408",
"marketing_category": "ANDA",
"nonproprietary_name": "Hydroxyzine",
"start_marketing_date": "20220117",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N05BB01.
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