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United States · US · US:50090-0878_3e351041-092e-4928-afd5-798f66c4dc9b
Diphenhydramine Hydrochloride
Orange BookSPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1150090087801 VIAL in 1 CARTON (50090-0878-0) / 50 mL in 1 VIAL
Annotations
Orange Book
A080817
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"48ede5ab-207b-cf0c-e063-6394a90a419f": {
"match": "brand_token",
"title": "DIPHENHYDRAMINE ORAL SOLUTION (DIPHENHYDRAMINE HCL12.5MG/5ML) SOLUTION [ALDAMA PHARMACEUTICALS, INC]",
"spl_version": "3",
"published_date": "2026-06-02"
}
},
"productid": "50090-0878_3e351041-092e-4928-afd5-798f66c4dc9b",
"productndc": "50090-0878",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "080817",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"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": "DIPHENHYDRAMINE HCL",
"proprietary_name": "Diphenhydramine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA080817",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenhydramine hydrochloride",
"start_marketing_date": "19721127",
"active_numerator_strength": "50"
}Related drugs
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