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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

  • ndc11
    2315526441
    25 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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