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United States · US · US:23155-264_94dd89a8-b3cd-45cf-abdd-ff383e3a24d9
Diphenhydramine Hydrochloride
Orange BookUNIISPLATC D04AA32
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
CountryUS (United States)
ATC codeD04AA32
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11231552644125 VIAL, GLASS in 1 PACKAGE (23155-264-41) / 1 mL in 1 VIAL, GLASS (23155-264-31)
Annotations
UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A205336
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": "23155-264_94dd89a8-b3cd-45cf-abdd-ff383e3a24d9",
"productndc": "23155-264",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "205336",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Jun 24, 2025"
}
],
"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": "ANDA205336",
"marketing_category": "ANDA",
"nonproprietary_name": "Diphenhydramine Hydrochloride",
"start_marketing_date": "20250630",
"active_numerator_strength": "50"
}Related drugs
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