SODIUM ACETATE

In shortageOrange BookUNIISPLATC B05XA08

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

Identification

ManufacturerAmneal Pharmaceuticals Private Limited

CountryUS (United States)

ATC codeB05XA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8083024362
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (80830-2436-2) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (80830-2436-1)

Annotations

UNII (FDA Substance ID)

NVG71ZZ7P0

SODIUM ACETATE ANHYDROUS

RxCUI 267453

Orange Book

A218469

APAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Sodium Chloride 0.9% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "NVG71ZZ7P0",
    "rxcui": "267453",
    "inchikey": "VMHLLURERBWHNL-UHFFFAOYSA-M",
    "display_name": "SODIUM ACETATE 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": "80830-2436_023c3b27-6c16-438b-b43d-7f9f27ceea7f",
  "productndc": "80830-2436",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "218469",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MEQ/50ML (2MEQ/ML)",
        "product_no": "001",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MEQ/100ML (2MEQ/ML)",
        "product_no": "002",
        "approval_date": "Aug 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MEQ/20ML (2MEQ/ML)",
        "product_no": "003",
        "approval_date": "Mar 2, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SODIUM ACETATE ANHYDROUS",
  "shortage_reason": "Sodium Chloride 0.9% Injection",
  "shortage_status": "current",
  "proprietary_name": "SODIUM ACETATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218469",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sodium acetate",
  "start_marketing_date": "20250812",
  "active_numerator_strength": "164"
}

Related drugs

Other records sharing ATC code B05XA08.

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