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United States · US · US:61621-430_96954bac-d035-4abc-b2cc-03c54a1459f7

Dsuvia

In shortageOrange BookUNIISPLATC N01AH03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAcelRx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN01AH03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6162143001
    1 TABLET in 1 POUCH (61621-430-01)
  • ndc11
    6162143011
    10 TABLET in 1 CARTON (61621-430-11)

Annotations

UNII (FDA Substance ID)
AFE2YW0IIZ
SUFENTANIL
RxCUI 56795
Orange Book
N209128
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Sufentanil Citrate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "AFE2YW0IIZ",
    "rxcui": "56795",
    "inchikey": "GGCSSNBKKAUURC-UHFFFAOYSA-N",
    "display_name": "SUFENTANIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBLINGUAL",
  "spl_meta": {
    "8b580f3d-e3b5-4086-b093-87a980631147": {
      "match": "brand_token",
      "title": "DSUVIA (SUFENTANIL) TABLET [ACELRX PHARMACEUTICALS, INC.]",
      "spl_version": "8",
      "published_date": "2026-05-13"
    }
  },
  "productid": "61621-430_96954bac-d035-4abc-b2cc-03c54a1459f7",
  "productndc": "61621-430",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209128",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.03MG BASE",
        "product_no": "001",
        "approval_date": "Nov 2, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUFENTANIL",
  "shortage_reason": "Sufentanil Citrate Injection",
  "shortage_status": "current",
  "proprietary_name": "Dsuvia",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA209128",
  "marketing_category": "NDA",
  "nonproprietary_name": "Sufentanil",
  "start_marketing_date": "20181102",
  "active_numerator_strength": "30"
}

Related drugs

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