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United States · US · US:72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2
Diphenhydramine Hydrochloride
Orange BookUNIISPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerArmas Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1172485101055 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-05) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)
- ndc11724851012525 VIAL, SINGLE-DOSE in 1 CARTON (72485-101-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-101-01)
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A205723
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": "72485-101_d949ac61-1864-4cf8-9b51-738b29952cc2",
"productndc": "72485-101",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "205723",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Aug 22, 2018"
}
],
"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": "ANDA205723",
"marketing_category": "ANDA",
"nonproprietary_name": "Diphenhydramine Hydrochloride",
"start_marketing_date": "20190501",
"active_numerator_strength": "50"
}Related drugs
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