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United States · US · US:50090-1841_8d155a86-c841-435e-9452-e1262e598072

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

  • ndc11
    5009018410
    25 VIAL in 1 PACKAGE (50090-1841-0) / 1 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": "50090-1841_8d155a86-c841-435e-9452-e1262e598072",
  "productndc": "50090-1841",
  "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

Other records sharing ATC code D04AA32.

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