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United States · US · US:68462-786_70c7710c-a354-4941-bd46-e64d6ea6b5dc

POTASSIUM PHOSPHATES

Orange BookUNIISPL

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

Identification

ManufacturerGLENMARK PHARMACEUTICALS INC., USA
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6846278625
    25 VIAL, SINGLE-DOSE in 1 CARTON (68462-786-25) / 5 mL in 1 VIAL, SINGLE-DOSE (68462-786-05)

Annotations

UNII (FDA Substance ID)
CI71S98N1Z
DIBASIC POTASSIUM PHOSPHATE
RxCUI 55018
Orange Book
A220373
APAPAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "CI71S98N1Z",
    "rxcui": "55018",
    "inchikey": "ZPWVASYFFYYZEW-UHFFFAOYSA-L",
    "display_name": "DIBASIC POTASSIUM PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "68462-786_70c7710c-a354-4941-bd46-e64d6ea6b5dc",
  "productndc": "68462-786",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "220373",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 12, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 12, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 12, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE",
  "proprietary_name": "POTASSIUM PHOSPHATES",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA220373",
  "marketing_category": "ANDA",
  "nonproprietary_name": "POTASSIUM PHOSPHATES",
  "start_marketing_date": "20260312",
  "active_numerator_strength": "236; 224"
}

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