Desmopressin Acetate

In shortageOrange BookUNIISPLATC H01BA02

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

Identification

ManufacturerGlenmark Pharmaceuticals Inc.,USA

CountryUS (United States)

ATC codeH01BA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6846227501
100 TABLET in 1 BOTTLE (68462-275-01)
ndc11
6846227510
1000 TABLET in 1 BOTTLE (68462-275-10)
ndc11
6846227530
30 TABLET in 1 BOTTLE (68462-275-30)
ndc11
6846227590
90 TABLET in 1 BOTTLE (68462-275-90)

Annotations

UNII (FDA Substance ID)

XB13HYU18U

DESMOPRESSIN ACETATE

RxCUI 42634

Orange Book

A201831

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": "68462-275_d9414e03-41d5-4e96-9ce6-b298c365281d",
  "productndc": "68462-275",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201831",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.1MG",
        "product_no": "001",
        "approval_date": "May 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.2MG",
        "product_no": "002",
        "approval_date": "May 28, 2015"
      }
    ],
    "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": "ANDA201831",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desmopressin Acetate",
  "start_marketing_date": "20150528",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code H01BA02.

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