Potassium Phosphates

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909707797
25 VIAL in 1 CARTON (69097-077-97) / 15 mL in 1 VIAL (69097-077-67)

Annotations

UNII (FDA Substance ID)

CI71S98N1Z

DIBASIC POTASSIUM PHOSPHATE

RxCUI 55018

Orange Book

A217892

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": "69097-077_2f2fccc5-9cbf-27d6-e063-6294a90a55f9",
  "productndc": "69097-077",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "217892",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
        "product_no": "002",
        "approval_date": "Jan 24, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
        "product_no": "003",
        "approval_date": "Jan 24, 2025"
      }
    ],
    "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": "ANDA217892",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Potassium Phosphates",
  "start_marketing_date": "20250206",
  "active_numerator_strength": "236; 224"
}

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