Sodium Phosphates

In shortageOrange BookUNIISPL

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517731525
25 VIAL, SINGLE-DOSE in 1 TRAY (0517-7315-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-7315-01)

Annotations

UNII (FDA Substance ID)

22ADO53M6F

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

RxCUI 314838

Orange Book

A218314

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "22ADO53M6F",
    "rxcui": "314838",
    "inchikey": "BNIILDVGGAEEIG-UHFFFAOYSA-L",
    "display_name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52430b12-4d5f-d1e1-e063-6394a90abd64": {
      "match": "brand_token",
      "title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0517-7315_4b71a79f-83da-45b0-a398-4833ecc17ba4",
  "productndc": "0517-7315",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "218314",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)",
        "product_no": "001",
        "approval_date": "Jun 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)",
        "product_no": "002",
        "approval_date": "Jun 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)",
        "product_no": "003",
        "approval_date": "Jun 21, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Phosphates",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA218314",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous",
  "start_marketing_date": "20240621",
  "active_numerator_strength": "142; 276"
}

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