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United States · US · US:84549-922_463df5df-3086-2160-e063-6294a90ac75f

Aminophylline

Orange BookUNIISPLATC R03DA55

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProPharma Distribution
CountryUS (United States)
ATC codeR03DA55
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8454992201
    20 mL in 1 VIAL, SINGLE-DOSE (84549-922-01)

Annotations

UNII (FDA Substance ID)
C229N9DX94
AMINOPHYLLINE DIHYDRATE
RxCUI 1298965
Orange Book
A087242
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "C229N9DX94",
    "rxcui": "1298965",
    "inchikey": "FXNJPZOEDHBGEY-UHFFFAOYSA-N",
    "display_name": "AMINOPHYLLINE DIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52bbc6cd-4baf-7859-e063-6394a90ac87d": {
      "match": "brand_token",
      "title": "AMINOPHYLLINE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "84549-922_463df5df-3086-2160-e063-6294a90ac75f",
  "productndc": "84549-922",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "087242",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/ML",
        "product_no": "001",
        "approval_date": "Oct 26, 1983"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMINOPHYLLINE DIHYDRATE",
  "proprietary_name": "Aminophylline",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA087242",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Aminophylline",
  "start_marketing_date": "20050228",
  "active_numerator_strength": "25"
}

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