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United States · US · US:51662-1649_19869100-35c6-c014-e063-6294a90a4f11
HYDROXYZINE HYDROCHLORIDE
Orange BookSPLATC N05BB01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeN05BB01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11516621649325 POUCH in 1 CASE (51662-1649-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1649-2) / 10 mL in 1 VIAL, MULTI-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": "51662-1649_19869100-35c6-c014-e063-6294a90a4f11",
"productndc": "51662-1649",
"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 HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA087408",
"marketing_category": "ANDA",
"nonproprietary_name": "HYDROXYZINE HYDROCHLORIDE",
"start_marketing_date": "19900930",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N05BB01.
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