NDC 61621-430

Dsuvia

Sufentanil

Dsuvia is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Acelrx Pharmaceuticals, Inc. The primary component is Sufentanil.

• Product ID: 61621-430_64d49a11-5597-4c89-aeea-ab6d2606ea7e
• NDC: 61621-430
• Product Type: Human Prescription Drug
• Proprietary Name: Dsuvia
• Generic Name: Sufentanil
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2018-11-02
• Marketing Category: NDA / NDA
• Application Number: NDA209128
• Labeler Name: AcelRx Pharmaceuticals, Inc
• Substance Name: SUFENTANIL
• Active Ingredient Strength: 30 ug/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 61621-430-01

1 TABLET in 1 POUCH (61621-430-01)

• Marketing Start Date: 2018-11-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 61621-430-11 [61621043011]

Dsuvia TABLET

• Marketing Category: NDA
• Application Number: NDA209128
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-02

NDC 61621-430-01 [61621043001]

Dsuvia TABLET

• Marketing Category: NDA
• Application Number: NDA209128
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-11-02

Drug Details

Active Ingredients

Ingredient	Strength
SUFENTANIL	30 ug/1

OpenFDA Data

• SPL SET ID: 8b580f3d-e3b5-4086-b093-87a980631147
• Manufacturer:
  • AcelRx Pharmaceuticals, Inc
• UNII:
  • AFE2YW0IIZ
• RxNorm Concept Unique ID - RxCUI:
  • 2103199
  • 2103192
• UPC Code:
  • 0361621430011

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]