Sodium Phosphates

In shortageOrange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332388116
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-881-16) / 15 mL in 1 VIAL, SINGLE-DOSE (63323-881-01)

Annotations

UNII (FDA Substance ID)

22ADO53M6F

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

RxCUI 314838

Orange Book

A209997

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Bicarbonate 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": "63323-881_3ae3c9a3-3503-4264-8c77-00089f50cc74",
  "productndc": "63323-881",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209997",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML)",
        "product_no": "001",
        "approval_date": "Mar 30, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)",
        "product_no": "002",
        "approval_date": "Mar 30, 2022"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML)",
        "product_no": "003",
        "approval_date": "Mar 30, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE",
  "shortage_reason": "Sodium Bicarbonate Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Phosphates",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA209997",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous",
  "start_marketing_date": "20220330",
  "active_numerator_strength": "142; 276"
}

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