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United States · US · US:68083-553_db7a3372-cd0e-412e-a8e2-90b5fdcf3e3e

ANGIOTENSIN II

Orange BookUNIISPLATC C01CX09

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

Identification

ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeC01CX09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6808355301
    1 VIAL, SINGLE-DOSE in 1 CARTON (68083-553-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
M089EFU921
ANGIOTENSIN II
RxCUI 1999003
Orange Book
A216966
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "M089EFU921",
    "rxcui": "1999003",
    "inchikey": null,
    "display_name": "ANGIOTENSIN II",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "727d1102-fc46-46f8-b78e-fd13f0738fe4": {
      "match": "brand_token",
      "title": "ANGIOTENSIN II INJECTION [GLAND PHARMA LIMITED]",
      "spl_version": "3",
      "published_date": "2025-06-05"
    }
  },
  "productid": "68083-553_db7a3372-cd0e-412e-a8e2-90b5fdcf3e3e",
  "productndc": "68083-553",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216966",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANGIOTENSIN II",
  "proprietary_name": "ANGIOTENSIN II",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216966",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ANGIOTENSIN II",
  "start_marketing_date": "20250603",
  "active_numerator_strength": "2.5"
}

Related drugs

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