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United States · US · US:70518-1082_485992c3-e3e0-e79a-e063-6294a90a655b
Diphenhydramine Hydrochloride
Orange BookUNIISPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11705181082125 VIAL in 1 PACKAGE (70518-1082-1) / 1 mL in 1 VIAL (70518-1082-0)
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A080817
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "TC2D6JAD40",
"rxcui": "1362",
"inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
"display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"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": "70518-1082_485992c3-e3e0-e79a-e063-6294a90a655b",
"productndc": "70518-1082",
"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 HYDROCHLORIDE",
"proprietary_name": "Diphenhydramine Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA080817",
"marketing_category": "ANDA",
"nonproprietary_name": "diphenhydramine hydrochloride",
"start_marketing_date": "20180327",
"active_numerator_strength": "50"
}Related drugs
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