Sodium Acetate

In shortageOrange BookUNIISPLATC B05XA08

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

Identification

ManufacturerMILLA PHARMACEUTICALS INC.

CountryUS (United States)

ATC codeB05XA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7135700810
10 VIAL, PHARMACY BULK PACKAGE in 1 CASE (71357-008-10) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (71357-008-01)

Annotations

UNII (FDA Substance ID)

4550K0SC9B

SODIUM ACETATE

RxCUI 237108

Orange Book

A214805

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "4550K0SC9B",
    "rxcui": "237108",
    "inchikey": "AYRVGWHSXIMRAB-UHFFFAOYSA-M",
    "display_name": "SODIUM ACETATE",
    "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": "71357-008_47d8d0e7-6db5-950d-e063-6294a90ab1bf",
  "productndc": "71357-008",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "214805",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MEQ/50ML (2MEQ/ML)",
        "product_no": "001",
        "approval_date": "May 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "400MEQ/100ML (4MEQ/ML)",
        "product_no": "002",
        "approval_date": "Aug 25, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MEQ/100ML (2MEQ/ML)",
        "product_no": "003",
        "approval_date": "May 4, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MEQ/20ML (2MEQ/ML)",
        "product_no": "004",
        "approval_date": "Jan 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM ACETATE",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "Sodium Acetate",
  "active_ingred_unit": "meq/100mL",
  "application_number": "ANDA214805",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Acetate Injection, USP, 200 mEq/100 mL",
  "start_marketing_date": "20241025",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code B05XA08.

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