FDA.reportPublic FDA data

Trutakna

Product NDC
85052-101
Requested package NDC
85052-101-04
11-digit product format
850520101
Labeler code
85052
Product ID
85052-101_83f672ee-5ed8-4226-aae7-16bb625f7088
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atacicept
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Vera Therapeutics, Inc
Application
BLA761486
Marketing category
BLA
Marketing start
2026-07-07
Substance
ATACICEPT
Active strength
150 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Trutakna
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATACICEPT150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D9A0ICQ3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2747237Internal RxNorm lookup
2747244Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24aa29f6-ccff-45d3-89af-4d26e525cef8Available on FDA.report

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
TrutaknaATACICEPTVera Therapeutics, Inc24aa29f6-ccff-45d3-89af-4d26e525cef82026-08-05Warnings, Adverse reactionsExact identifier
application number: BLA761486
ndc (package): 85052-101-04
ndc (product): 85052-101
ndc11 (package): 85052010104

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761486Trutaknaatacicept-vymj351(a)Rx2026-09-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85052-101-04850520101044 SYRINGE, GLASS in 1 CARTON (85052-101-04) / 1 INJECTION, SOLUTION in 1 SYRINGE, GLASS (85052-101-01) 2026-07-07NoNoCurrent