NDC 0074-1040

Survanta

Beractant

Survanta is a Endotracheal Suspension in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Beractant.

• Product ID: 0074-1040_2071a89e-e518-485b-ac2b-41721b0a98b5
• NDC: 0074-1040
• Product Type: Human Prescription Drug
• Proprietary Name: Survanta
• Generic Name: Beractant
• Dosage Form: Suspension
• Route of Administration: ENDOTRACHEAL
• Marketing Start Date: 1991-07-01
• Marketing Category: BLA / NDA
• Application Number: BLA020032
• Labeler Name: AbbVie Inc.
• Substance Name: BERACTANT
• Active Ingredient Strength: 25 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0074-1040-04

1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) > 4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1991-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0074-1040-08 [00074104008]

Survanta SUSPENSION

• Marketing Category: BLA
• Application Number: BLA020032
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1991-07-01

NDC 0074-1040-04 [00074104004]

Survanta SUSPENSION

• Marketing Category: BLA
• Application Number: BLA020032
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1991-07-01

Drug Details

Active Ingredients

Ingredient	Strength
BERACTANT	25 mg/mL

OpenFDA Data

• SPL SET ID: 7ef9e3a5-fc39-4ae1-0dad-6b47a1684635
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • S866O45PIG
• RxNorm Concept Unique ID - RxCUI:
  • 861715
  • 259034

Pharmacological Class

• Alveolar Surface Tension Reduction [PE]
• Surfactant [EPC]
• Surfactant Activity [MoA]