FDA.reportPublic FDA data

Survanta

Product NDC
0074-1040
11-digit product format
000741040
Labeler code
0074
Product ID
0074-1040_6ff1e6a7-1578-4e78-b34f-eb204b23554c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Beractant
Dosage form
SUSPENSION
Route
ENDOTRACHEAL
Labeler
AbbVie Inc.
Application
BLA020032
Marketing category
BLA
Marketing start
1991-07-01
Substance
BERACTANT
Active strength
25 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Survanta
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BERACTANT25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S866O45PIGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259034Internal RxNorm lookup
861715Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ef9e3a5-fc39-4ae1-0dad-6b47a1684635Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18f1257-2899-86b6-947e-8e6a3d79b556Product name220210126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-1040-04Survanta1 in 1 CARTONSUSPENSION146
0074-1040-04Survanta4 mL in 1 VIAL, SINGLE-USESUSPENSION446
0074-1040-08Survanta8 mL in 1 VIAL, SINGLE-USESUSPENSION846
0074-1040-08Survanta1 in 1 CARTONSUSPENSION146

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-1040-04ML - Milliliter0074-10406af7f63f-a1d3-411d-8fcc-12807dbbdb8a12012-07-24
0074-1040-08ML - Milliliter0074-104083339f19-bb04-4d29-8157-e18b6a1061f212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BERACTANTACTIVE INGREDIENTS866O45PIGSURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
CALFACTANTACTIVE MOIETYQ4K217VGA9SURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
COLFOSCERIL PALMITATEINACTIVE INGREDIENT319X2NFW0ASURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1SURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
TRIPALMITININACTIVE INGREDIENTD133ZRF50USURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RSURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-1040SURVANTA (BERACTANT) SUSPENSION [ABBVIE INC.]46Current NDC, Legacy NDC, 4 package rows20240302_7ef9e3a5-fc39-4ae1-0dad-6b47a1684635.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurvantaBERACTANTAbbVie Inc.7ef9e3a5-fc39-4ae1-0dad-6b47a16846352020-10-15Warnings, Adverse reactionsExact identifier
application number: BLA020032
ndc (product): 0074-1040

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020032Survantaberactant351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259034beractant 25 MG/ML Intratracheal SuspensionPSN7ef9e3a5-fc39-4ae1-0dad-6b47a168463546
861715SURVANTA 25 MG/ML Intratracheal SuspensionPSN7ef9e3a5-fc39-4ae1-0dad-6b47a168463546
861715beractant 25 MG/ML Intratracheal Suspension [Survanta]SBD7ef9e3a5-fc39-4ae1-0dad-6b47a168463546
259034beractant 25 MG/ML Intratracheal SuspensionSCD7ef9e3a5-fc39-4ae1-0dad-6b47a168463546
861715Survanta 25 MG/ML Intratracheal SuspensionSY7ef9e3a5-fc39-4ae1-0dad-6b47a168463546

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0074-1040-04000741040041 VIAL, SINGLE-USE in 1 CARTON (0074-1040-04) / 4 mL in 1 VIAL, SINGLE-USE1991-07-010000-00-00NoNoCurrent
0074-1040-08000741040081 VIAL, SINGLE-USE in 1 CARTON (0074-1040-08) / 8 mL in 1 VIAL, SINGLE-USE1991-07-010000-00-00NoNoCurrent