survanta

Generic: beractant

Labeler: abbvie inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name survanta
Generic Name beractant
Labeler abbvie inc.
Dosage Form SUSPENSION
Routes
ENDOTRACHEAL
Active Ingredients

beractant 25 mg/mL

Manufacturer
AbbVie Inc.

Identifiers & Regulatory

Product NDC 0074-1040
Product ID 0074-1040_6ff1e6a7-1578-4e78-b34f-eb204b23554c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA020032
Listing Expiration 2026-12-31
Marketing Start 1991-07-01

Pharmacologic Class

Established (EPC)
surfactant [epc]
Mechanism of Action
surfactant activity [moa]
Physiologic Effect
alveolar surface tension reduction [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00741040
Hyphenated Format 0074-1040

Supplemental Identifiers

RxCUI
259034 861715
UNII
S866O45PIG
NUI
N0000008294 N0000175778 N0000000079

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name survanta (source: ndc)
Generic Name beractant (source: ndc)
Application Number BLA020032 (source: ndc)
Routes
ENDOTRACHEAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) / 4 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08) / 8 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

0074-1040-04 1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) / 4 mL in 1 VIAL, SINGLE-USE 0074-1040-08 1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08) / 8 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

beractant (25 mg/mL)

Linked Drug Pages (1)

Survanta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ENDOTRACHEAL"], "spl_id": "6ff1e6a7-1578-4e78-b34f-eb204b23554c", "openfda": {"nui": ["N0000008294", "N0000175778", "N0000000079"], "unii": ["S866O45PIG"], "rxcui": ["259034", "861715"], "spl_set_id": ["7ef9e3a5-fc39-4ae1-0dad-6b47a1684635"], "pharm_class_pe": ["Alveolar Surface Tension Reduction [PE]"], "pharm_class_epc": ["Surfactant [EPC]"], "pharm_class_moa": ["Surfactant Activity [MoA]"], "manufacturer_name": ["AbbVie Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04)  / 4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0074-1040-04", "marketing_start_date": "19910701"}, {"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08)  / 8 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0074-1040-08", "marketing_start_date": "19910701"}], "brand_name": "Survanta", "product_id": "0074-1040_6ff1e6a7-1578-4e78-b34f-eb204b23554c", "dosage_form": "SUSPENSION", "product_ndc": "0074-1040", "generic_name": "Beractant", "labeler_name": "AbbVie Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Survanta", "active_ingredients": [{"name": "BERACTANT", "strength": "25 mg/mL"}], "application_number": "BLA020032", "marketing_category": "BLA", "marketing_start_date": "19910701", "listing_expiration_date": "20261231"}