Sodium Acetate

In shortageOrange BookUNIISPLATC B05XA08

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeB05XA08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0641626310
10 VIAL in 1 CARTON (0641-6263-10) / 100 mL in 1 VIAL (0641-6263-01)

Annotations

UNII (FDA Substance ID)

NVG71ZZ7P0

SODIUM ACETATE ANHYDROUS

RxCUI 267453

Orange Book

A216920

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": "0641-6263_777b7564-f07b-401a-a042-0cd512ae3b25",
  "productndc": "0641-6263",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216920",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "40MEQ/20ML (2MEQ/ML)",
        "product_no": "001",
        "approval_date": "Mar 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MEQ/50ML (2MEQ/ML)",
        "product_no": "002",
        "approval_date": "Mar 15, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "200MEQ/100ML (2MEQ/ML)",
        "product_no": "003",
        "approval_date": "Mar 15, 2024"
      }
    ],
    "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": "ANDA216920",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Acetate",
  "start_marketing_date": "20240520",
  "active_numerator_strength": "164"
}

Related drugs

Other records sharing ATC code B05XA08.

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