Desmopressin Acetate

In shortageOrange BookUNIISPLATC H01BA02

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

Identification

ManufacturerREMEDYREPACK INC.

CountryUS (United States)

ATC codeH01BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7051846120
50 POUCH in 1 BOX (70518-4612-0) / 1 TABLET in 1 POUCH (70518-4612-1)

Annotations

UNII (FDA Substance ID)

XB13HYU18U

DESMOPRESSIN ACETATE

RxCUI 42634

Orange Book

A213095

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Desmopressin Acetate Spray

Raw payload (JSON)

{
  "unii": {
    "unii": "XB13HYU18U",
    "rxcui": "42634",
    "inchikey": "YNKFCNRZZPFMEX-XHPDKPNGSA-N",
    "display_name": "DESMOPRESSIN ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f140926e-3201-4b8e-8207-14c560ddb55e": {
      "match": "brand_token",
      "title": "DESMOPRESSIN ACETATE TABLET [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-04-27"
    }
  },
  "productid": "70518-4612_50265f49-069b-8985-e063-6394a90af552",
  "productndc": "70518-4612",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213095",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "Mar 21, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "Mar 21, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DESMOPRESSIN ACETATE",
  "shortage_reason": "Desmopressin Acetate Spray",
  "shortage_status": "current",
  "proprietary_name": "Desmopressin Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213095",
  "marketing_category": "ANDA",
  "nonproprietary_name": "desmopressin acetate",
  "start_marketing_date": "20260423",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code H01BA02.

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