SODIUM PHOSPHATES

In shortageOrange BookUNIISPL

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

Identification

ManufacturerCaplin Steriles Limited

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6514520225
25 VIAL, SINGLE-DOSE in 1 CARTON (65145-202-25) / 50 mL in 1 VIAL, SINGLE-DOSE (65145-202-01)

Annotations

UNII (FDA Substance ID)

70WT22SF4B

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

RxCUI 221090

Orange Book

A220683

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "70WT22SF4B",
    "rxcui": "221090",
    "inchikey": "PYLIXCKOHOHGKQ-UHFFFAOYSA-L",
    "display_name": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
    "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": "65145-202_46de992b-5fc8-4dad-8d95-77938decb67e",
  "productndc": "65145-202",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "220683",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML)",
        "product_no": "002",
        "approval_date": "Feb 23, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML)",
        "product_no": "003",
        "approval_date": "Feb 23, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; 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": "ANDA220683",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM PHOSPHATES",
  "start_marketing_date": "20260310",
  "active_numerator_strength": "268; 276"
}

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