NDC 0074-1040-08 (billing 00074-1040-08) — Survanta Beractant 25 mg/mL

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0074-1040-08

Product NDC 0074-1040

11-digit billing NDC 00074104008

NCPDP billing unit ML — per mL (volume)

RxCUI 259034, 861715

UNII S866O45PIG

Application # BLA020032

SPL Set ID 7ef9e3a5-fc39-4ae1-0dad-6b47a1684635

Established class (EPC) Surfactant

Mechanism of action Surfactant Activity

Physiologic effect Alveolar Surface Tension Reduction

DEA schedule Non-controlled

Marketing category BLA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 1991-07-01

Route ENDOTRACHEAL

Dosage form SUSPENSION

Substance BERACTANT

Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 45000050111820

GPI class Survanta

GCN Seq No 016280

GCN 02871

HICL code 006193

Ingredient (HICL) Beractant

HIC1 code B

Therapeutic class — broad (HIC1) Respiratory System

HIC2 code B1

Therapeutic class — intermediate (HIC2) Affect Primarily Lungs

HIC3 code B1A

Therapeutic class — specific (HIC3) Lung Surfactants

AHFS code 48:36.00.00

AHFS class Pulmonary Surfactants

FDB label name SURVANTA 25 MG/ML VIAL

FDB brand name Survanta

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 016280
GCN: 02871
GPI-14 (Medi-Span): 45000050111820
HICL (First Databank): 006193
AHFS class code: 48:36.00.00
RxCUI (RxNorm): 259034

Why two NDCs? The FDA registers this code as 0074-1040-08 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00074-1040-08. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA label on DailyMed · label index refreshed Oct 8, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 8, 2026

Clinical

Label name SURVANTA 25 MG/ML VIAL Ingredient Beractant

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

MedlinePlus (NLM) · refreshed Oct 8, 2026
FDA label on DailyMed · label index refreshed Oct 8, 2026

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 4 mL

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
00074-1040-04 0074-1040-04 Main listing	1 VIAL, SINGLE-USE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-USE	1991-07-01	—	Active
00074-1040-08 You're viewing this	1 VIAL, SINGLE-USE in 1 CARTON / 8 mL in 1 VIAL, SINGLE-USE	1991-07-01	—	Active

Pack size FAQ

What quantity is in this package?

This package is listed by the FDA — 1 vial, single-use in 1 carton / 8 ml in 1 vial, single-use.

What NDC number is used to bill for this package of Survanta Beractant 25 mg/mL Suspension?

Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Survanta 25 mg/mLthis 00074-1040-08	AbbVie	1 vial	—	—	FDA listed	—

About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 8, 2026
FDA Purple Book · refreshed Oct 5, 2026
CMS NADAC weekly file

Availability & biosimilar status

🏛️

1991

First FDA approval

Jul 1991

📍

2026

Currently FDA-listed

35 years listed

🧬

·

Biosimilars

see Purple Book

🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

FDA Purple Book — biosimilars & interchangeables ⓘ

Reference product

Survantaberactant

🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.

Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.

Where does this data come from?

Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

FDA Purple Book · refreshed Oct 5, 2026

What it looks like

Color white

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

FDA label on DailyMed · label index refreshed Oct 8, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 319X2NFW0A
Colfosceril palmitate is a synthetic compound that mimics natural lung surfactant. It's used in some medicines as an active pharmaceutical ingredient or formulation component to help the product spread and be absorbed effectively in the lungs.
UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
UNII 2V16EO95H1
Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
UNII D133ZRF50U
A saturated fat derived from palm oil, used as a binder and hardening agent to give tablets and capsules their solid structure and help them hold together during manufacturing and storage.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

FDA label on DailyMed · label index refreshed Oct 8, 2026
FDA openFDA NDC Directory · synced Oct 8, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAbbVie Inc.

FDA applicationBLA020032 (BLA)

Labeler code00074

First marketedJul 1991

Product typeHuman Prescription Drug

Portfolio129 products on file

More NDCs from AbbVie Inc. labeler code 00074

🔎 All NDCs from AbbVie Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA openFDA NDC Directory · synced Oct 8, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 22 words ▾

INDICATIONS AND USAGE SURVANTA is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Important Administration Instructions For intratracheal administration only. SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The administration of SURVANTA is facilitated if one person administers the dose while another person positions and monitors the infant.

Before administering SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing.

Administer SURVANTA intratracheally by instillation through a 5 French end-hole catheter. Recommended Dosage Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). In the prevention strategy, in premature infants with evidence of surfactant deficiency, give the first dose of SURVANTA as soon as possible, preferably within 15 minutes of birth.

To treat infants with RDS confirmed by radiographic and clinical findings, give the first dose of SURVANTA as soon as possible, preferably by 8 hours of age. Four doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every 6 hours.

The need for additional doses of SURVANTA is determined by evidence of continuing respiratory distress. Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose. Preparation of the SURVANTA Suspension SURVANTA should be inspected visually for discoloration prior to administration.

The color of SURVANTA is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Do not filter SURVANTA.

Some foaming at the surface may occur during handling and is inherent in the nature of the product. SURVANTA is stored refrigerated (36°F to 46°F [2°C to 8°C]). Date and time need to be recorded in the box on front of the carton or vial, whenever SURVANTA is removed from the refrigerator.

Before administration, SURVANTA should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. Artificial warming methods should not be used. If a prevention dose is to be given, preparation of SURVANTA should begin before the infant’s birth.

Unopened, unused vials of SURVANTA that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming, and stored for future use. SURVANTA SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. SURVANTA SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE.

Each single-dose vial of SURVANTA should be entered only once. Used vials with residual drug should be discarded. SURVANTA does not require reconstitution or sonication before use.

Administration For endotracheal administration using a 5 French end-hole catheter: 1. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (e.g., at least 20 gauge). 2.

Attach the premeasured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA. Discard excess SURVANTA through the catheter so that only the total dose to be given remains in the syringe.

3. When administering SURVANTA using a 5 French end-hole catheter, administer in four quarter-dose aliquots. Each quarter-dose is administered with the infant in a different position: Head and body inclined 5-10° down, head turned to the right Head and body inclined 5-10° down, head turned to the left Head and body inclined 5-10° up, head turned to the right Head and body inclined 5-10° up, head turned to the left 4.

First quarter-dose aliquot of SURVANTA suspension: a. Position the infant appropriately in one of the four recommended positions. b. Insert the 5-French end-hole catheter into the endotracheal tube.

The tip of… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 2 words ▾

CONTRAINDICATIONS None

⚠️ Warnings 97 words ▾

WARNINGS SURVANTA can rapidly affect oxygenation and lung compliance within minutes of administration of SURVANTA. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.

During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS The most commonly reported adverse experiences were associated with the dosing procedure. In the multiple-dose controlled clinical trials, each dose of SURVANTA was divided into four quarter-doses which were instilled through a catheter inserted into the endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator. Transient bradycardia occurred with 11.9% of doses .

Oxygen desaturation occurred with 9.8% of doses . Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.

The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in Table 3. Table 3.

All Controlled Studies Concurrent Event SURVANTA (%) Control (%) P -Value a Patent ductus arteriosus 46.9 47.1 0.814 Intracranial hemorrhage 48.1 45.2 0.241 Severe intracranial hemorrhage 24.1 23.3 0.693 Pulmonary air leaks 10.9 24.7 < 0.001 Pulmonary interstitial emphysema 20.2 38.4 < 0.001 Necrotizing enterocolitis 6.1 5.3 0.427 Apnea 65.4 59.6 0.283 Severe apnea 46.1 42.5 0.114 Post-treatment sepsis 20.7 16.1 0.019 Post-treatment infection 10.2 9.1 0.345 Pulmonary hemorrhage 7.2 5.3 0.166 a P -value comparing groups in controlled studies When all controlled studies were pooled, there was no difference in intracranial hemorrhage.

However, in one of the single-dose rescue studies and one of the multiple-dose prevention studies, the rate of intracranial hemorrhage was significantly higher in SURVANTA patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively). The rate in a Treatment IND involving approximately 8100 infants was lower than in the controlled trials. In the controlled clinical trials, there was no effect of SURVANTA on results of common laboratory tests: white blood cell count and serum sodium, potassium, bilirubin, and creatinine.

More than 4300 pretreatment and post-treatment serum samples from approximately 1500 patients were tested by Western Blot Immunoassay for antibodies to surfactant-associated proteins SP-B and SP-C. No IgG or IgM antibodies were detected. Several other complications are known to occur in premature infants.

The following conditions were reported in the controlled clinical studies. The rates of the complications were not different in treated and control infants, and none of the complications were attributed to SURVANTA. Respiratory lung consolidation, blood from the endotracheal tube, deterioration after weaning, respiratory decompensation, subglottic stenosis, paralyzed diaphragm, respiratory failure.

Cardiovascular hypotension, hypertension, tachycardia, ventricular tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory arrest, increased apical pulse, persistent fetal circulation, air embolism, total anomalous pulmonary venous return. Gastrointestinal abdominal distention, hemorrhage, intestinal perforations, volvulus, bowel infarct, feeding intolerance, hepatic failure, stress ulcer. Renal renal failure, hematuria.

Hematologic coagulopathy, thrombocytopenia, disseminated intravascular coagulation. Central Nervous System seizures Endocrine/Metabolic adrenal hemorrhage, inappropriate ADH secretion, hyperphosphatemia. Musculoskeletal inguinal hernia.

Systemic fever, deterioration. Follow-Up Evaluations To date, no long-term complications or sequelae of SURVANTA therapy have been found. Single-Dose Studies Six-month adjusted-age follow-up evaluations of 232 infants (115 treated) demonstrated no clinically important differences between treatment groups in pulmonary and neurologic sequelae, incidence or severity of retinopathy of prematurity, rehospitalizations, growth, or allergic mani… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 59 words ▾

OVERDOSAGE Overdosage with SURVANTA has not been reported. Based on animal data, overdosage might result in acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after SURVANTA is given, and do not indicate overdosage. Endotracheal suctioning or other remedial action is not required unless clear-cut signs of airway obstruction are present.

🧬 Clinical Pharmacology ~1 min read ▾

CLINICAL PHARMACOLOGY Endogenous pulmonary surfactant lowers surface tension on alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. Deficiency of pulmonary surfactant causes Respiratory Distress Syndrome (RDS) in premature infants. SURVANTA replenishes surfactant and restores surface activity to the lungs of these infants.

Activity In vitro, SURVANTA reproducibly lowers minimum surface tension to less than 8 dynes/cm as measured by the pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, SURVANTA restores pulmonary compliance to excised rat lungs artificially made surfactant-deficient. In vivo, single SURVANTA doses improve lung pressure-volume measurements, lung compliance, and oxygenation in premature rabbits and sheep.

Animal Metabolism SURVANTA is administered directly to the target organ, the lungs, where biophysical effects occur at the alveolar surface. In surfactant-deficient premature rabbits and lambs, alveolar clearance of radio-labelled lipid components of SURVANTA is rapid. Most of the dose becomes lung-associated within hours of administration, and the lipids enter endogenous surfactant pathways of reutilization and recycling.

In surfactant-sufficient adult animals, SURVANTA clearance is more rapid than in premature and young animals. There is less reutilization and recycling of surfactant in adult animals. Limited animal experiments have not found effects of SURVANTA on endogenous surfactant metabolism.

Precursor incorporation and subsequent secretion of saturated phosphatidylcholine in premature sheep are not changed by SURVANTA treatments. No information is available about the metabolic fate of the surfactant-associated proteins in SURVANTA. The metabolic disposition in humans has not been studied.

📦 How Supplied / Storage and Handling 103 words ▾

HOW SUPPLIED SURVANTA (beractant) intratracheal suspension is supplied in 100 mg/4 mL single-dose glass vials (NDC 0074-1040-04) or 200 mg/8 mL single-dose glass vials (NDC 0074-1040-08). Each mL contains 25 mg of phospholipids suspended in 0.9% sodium chloride solution. The color is off-white to light brown.

Store unopened vials refrigerated at 36°F to 46°F (2°C to 8°C). Do not shake. Protect from light.

Store vials in carton until ready for use. Vials are for one-time use and for only one patient. Upon opening, discard unused drug.

LITHO IN USA AbbVie Inc. North Chicago, IL 60064, U.S.A. US License Number 1889 20065798 October, 2020

📋 Description 172 words ▾

DESCRIPTION SURVANTA ® contains beractant, a pulmonary surfactant, which is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins (SP) to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL of phospholipids (including 11.0-15.5 mg/mL of disaturated phosphatidylcholine), 0.5-1.75 mg/mL of triglycerides, 1.4-3.5 mg/mL of free fatty acids, and less than 1 mg/mL of SP (including SP-B, a 79-amino acid protein, and SP-C, a 35-amino acid peptide).

SURVANTA (beractant) intratracheal suspension is a sterile, preservative-free, non-pyrogenic off-white to light brown liquid supplied in single-dose glass vials for intratracheal use only. Each vial contains 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids). Each mL of SURVANTA contains 25 mg of phospholipids.

It is suspended in 0.9% sodium chloride solution and heat-sterilized. SURVANTA contains no preservatives. Sodium hydroxide or hydrochloric acid may be added to adjust the pH.

The pH is approximately 6.2 to 7.6.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present. Increased probability of post-treatment nosocomial sepsis in SURVANTA-treated infants was observed in the controlled clinical trials (Table 3).

The increased risk for sepsis among SURVANTA-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.

Use of SURVANTA in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of SURVANTA in conjunction with experimental therapies for RDS (eg, high-frequency ventilation or extracorporeal membrane oxygenation). No information is available on the effects of doses other than 100 mg phospholipids/kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with SURVANTA. SURVANTA was negative when tested in the Ames test for mutagenicity. Using the maximum feasible dose volume, SURVANTA up to 500 mg phospholipids/kg/day (approximately one-third the premature infant dose based on mg/m 2 /day) was administered subcutaneously to newborn rats for 5 days.

The rats reproduced normally and there were no observable adverse effects in their offspring.

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES Clinical effects of SURVANTA were demonstrated in six single-dose and four multiple-dose randomized, multi-center, controlled clinical trials involving approximately 1700 infants. Three open trials, including a Treatment IND, involved more than 8500 infants. Each dose of SURVANTA in all studies was 100 mg phospholipids/kg birth weight and was based on published experience with Surfactant TA, a lyophilized powder dosage form of SURVANTA having the same composition.

SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications. Prevention Studies Infants of 600-1250 g birth weight and 23 to 29 weeks estimated gestational age were enrolled in two multiple-dose studies. A dose of SURVANTA was given within 15 minutes of birth to prevent the development of RDS.

Up to three additional doses in the first 48 hours, as often as every 6 hours, were given if RDS subsequently developed and infants required mechanical ventilation with an FiO 2 ≥ 0.30. Results of the studies at 28 days of age are shown in Table 1. Table 1.

Study 1 SURVANTA Control P -Value Number infants studied 119 124 Incidence of RDS (%) 27.6 63.5 < 0.001 Death due to RDS (%) 2.5 19.5 < 0.001 Death or BPD due to RDS (%) 48.7 52.8 0.536 Death due to any cause (%) 7.6 22.8 0.001 Air Leaks a (%) 5.9 21.7 0.001 Pulmonary interstitial emphysema (%) 20.8 40.0 0.001 Study 2 b SURVANTA Control P -Value Number infants studied 91 96 Incidence of RDS (%) 28.6 48.3 0.007 Death due to RDS (%) 1.1 10.5 0.006 Death or BPD due to RDS (%) 27.5 44.2 0.018 Death due to any cause C (%) 16.5 13.7 0.633 Air Leaks a (%) 14.5 19.6 0.374 Pulmonary interstitial emphysema (%) 26.5 33.2 0.298 a Pneumothorax or pneumopericardium b Study discontinued when Treatment IND initiated c No cause of death in the SURVANTA group was significantly increased; the higher number of deaths in this group was due to the sum of all causes.

Rescue Studies Infants of 600-1750 g birth weight with RDS requiring mechanical ventilation and an FiO 2 ≥ 0.40 were enrolled in two multiple-dose rescue studies. The initial dose of SURVANTA was given after RDS developed and before 8 hours of age. Infants could receive up to three additional doses in the first 48 hours, as often as every 6 hours, if they required mechanical ventilation and an FiO 2 ≥ 0.30.

Results of the studies at 28 days of age are shown in Table 2. Table 2. Study 3 a SURVANTA Control P -Value Number infants studied 198 193 Death due to RDS (%) 11.6 18.1 0.071 Death or BPD due to RDS (%) 59.1 66.8 0.102 Death due to any cause (%) 21.7 26.4 0.285 Air Leaks b (%) 11.8 29.5 <0.001 Pulmonary interstitial emphysema (%) 16.3 34.0 <0.001 Study 4 SURVANTA Control P -Value Number infants studied 204 203 Death due to RDS (%) 6.4 22.3 < 0.001 Death or BPD due to RDS (%) 43.6 63.4 < 0.001 Death due to any cause (%) 15.2 28.2 0.001 Air Leaks b (%) 11.2 22.2 0.005 Pulmonary interstitial emphysema (%) 20.8 44.4 < 0.001 a Study discontinued when Treatment IND initiated b Pneumothorax or pneumopericardium Acute Clinical Effects Marked improvements in oxygenation may occur within minutes of administration of SURVANTA.

All controlled clinical studies with SURVANTA provided information regarding the acute effects of SURVANTA on the arterial-alveolar oxygen ratio (a/APO 2 ), FiO 2 , and mean airway pressure (MAP) during the first 48 to 72 hours of life. Significant improvements in these variables were sustained for 48-72 hours in SURVANTA-treated infants in four single-dose and two multiple-dose rescue studies and in two multiple-dose prevention studies. In the single-dose prevention studies, the FiO 2 improved significantly.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 70 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with SURVANTA. SURVANTA was negative when tested in the Ames test for mutagenicity. Using the maximum feasible dose volume, SURVANTA up to 500 mg phospholipids/kg/day (approximately one-third the premature infant dose based on mg/m 2 /day) was administered subcutaneously to newborn rats for 5 days.

The rats reproduced normally and there were no observable adverse effects in their offspring.

📄 Package Label / Principal Display Panel 187 words ▾

Principal Display Panel NDC 0074-1040-08 8 mL One Single-Dose Vial beractant SURVANTA ® intratracheal suspension 200 mg/8 mL (25 mg/mL) For Intratracheal Administration Only Sterile Suspension Store refrigerated between 36 º F to 46 º F (2 º C to 8 º C). DO NOT SHAKE. PROTECT FROM LIGHT.

Rx only abbvie NDC 0074-1040-08 8 mL One Single-Dose Vial beractant SURVANTA® intratracheal suspension 200 mg/8 mL (25 mg/mL) For Intratracheal Administration Only Sterile Suspension Store refrigerated between 36ºF to 46ºF (2ºC to 8ºC). DO NOT SHAKE. PROTECT FROM LIGHT.

Rx only abbvie

Principal Display Panel NDC 0074-1040-04 4 mL One Single-Dose Vial beractant SURVANTA ® intratracheal suspension 100 mg/4 mL (25 mg/mL) For Intratracheal Administration Only Sterile Suspension Store refrigerated between 36 º F to 46 º F (2 º C to 8 º C). DO NOT SHAKE. PROTECT FROM LIGHT.

Rx only abbvie Principal Display Panel NDC 0074-1040-04 4 mL One Single-Dose Vial beractant SURVANTA® intratracheal suspension 100 mg/4 mL (25 mg/mL) For Intratracheal Administration Only Sterile Suspension Store refrigerated between 36ºF to 46ºF (2ºC to 8ºC). DO NOT SHAKE. PROTECT FROM LIGHT.

Rx only abbvie

Glossary — plain-language definitions of medical terms used in this label:

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

in vivo: In a living person or animal rather than in a laboratory dish.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

apnea: A pause or temporary stop in breathing.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Carcinogenesis, Mutagenesis, Impairment of Fertility: A label section reporting whether lab or animal studies found effects on cancer risk, genes, or the ability to have children.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

coagulopathy: A problem with the blood's ability to clot properly, which can cause too much bleeding or unwanted clotting.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

disseminated intravascular coagulation: A serious condition where many small clots form throughout the body, using up the proteins needed to clot and causing bleeding.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dosage form: The physical form a medicine comes in, such as a tablet, capsule, liquid, patch, or injection.

embolism: A blockage of a blood vessel by a clot or other material that has traveled from elsewhere in the body.

fertility: The natural ability to become pregnant or to father a child.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

hematuria: Blood in the urine.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hyperphosphatemia: A higher-than-normal level of phosphate, a mineral, in the blood.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

lyophilized: Freeze-dried into a powder that is mixed with liquid before it is given.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

oxygen saturation: A measurement, shown as a percentage, of how much oxygen the red blood cells are carrying.

pallor: Unusual paleness of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

reconstitution: Mixing a powdered medicine with a liquid to prepare it for use, following the label's directions.

respiratory failure: A serious condition in which the lungs cannot get enough oxygen into the blood or remove enough carbon dioxide.

retinopathy: Damage to the retina, the light-sensing layer at the back of the eye, which can affect vision.

Rx only: A label marking meaning the medicine can be obtained only with a prescription from a licensed health professional.

sepsis: A serious, body-wide reaction to an infection in which the body's own response can start to injure its tissues and organs.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

vasoconstriction: Narrowing of blood vessels, which reduces blood flow through them and can raise blood pressure.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Survanta (this brand).

Top reported reactions

Pulmonary Haemorrhage125

Death54

Neurodevelopmental Disorder36

Pneumothorax34

Sepsis19

Endotracheal Intubation Complication16

Neonatal Disorder16

Age at onset

Neonate38

Infant7

Reporter sex

Male · 44%

Female · 28%

Unknown · 28%

Serious outcomes

Hospitalization72

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

FDA Adverse Event Reporting System (FAERS)

About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AbbVie Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00074-1040-04). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

AbbVie Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

Related NDC lookups

🧪 All Beractant NDCsSame ingredient 🏭 All AbbVie labeler NDCsLabeler code 00074

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Lung Surfactants.

Poractant Alfa 10122-0510-01 Calfactant 61938-0456-03

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 8, 2026

Survanta Beractant 25 mg/mL Suspension — NDC 0074-1040-08 (Billing 00074-1040-08)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Pack size FAQ

Therapeutic equivalents

Availability & biosimilar status

What it looks like

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from AbbVie Inc. labeler code 00074

Full prescribing information FDA SPL

Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

About this NDC listing & data coverage

Questions about this listing