FDA.reportPublic FDA data

AMVUTTRA

Product NDC
71336-1003
11-digit product format
713361003
Labeler code
71336
Product ID
71336-1003_1791a81a-d261-4b66-b699-273afe02c380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VUTRISIRAN
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Alnylam Pharmaceuticals, Inc.
Application
NDA215515
Marketing category
NDA
Marketing start
2022-06-13
Substance
VUTRISIRAN SODIUM
Active strength
25 mg/.5mL
Pharmacologic classes
Decreased RNA Integrity [PE], Increased Protein Breakdown [PE], RNA, Small Interfering [CS], Small Interfering RNA [EPC], Transthyretin-directed RNA Interaction [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VUTRISIRAN SODIUM25 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii28O0WP6Z1P
Rxcui2604788, 2604794

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
13d3bd13-5634-4682-9348-7ee2710acc8bProduct name120230310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71336-1003-1AMVUTTRA1 in 1 CARTONINJECTION18
71336-1003-1AMVUTTRA0.5 mL in 1 SYRINGE, GLASSINJECTION0.58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71336-1003-1ML - Milliliter71336-1003e88da143-aa5e-412f-a03f-cc540e1bc7b312022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71336-1003AMVUTTRA (VUTRISIRAN) INJECTION [ALNYLAM PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 2 package rows20250331_8db0facb-81b6-4006-9239-27dc6409c5d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604794amvuttra 25 MG in 0.5 ML Prefilled SyringePSN8db0facb-81b6-4006-9239-27dc6409c5d38
2604788vutrisiran 25 MG in 0.5 ML Prefilled SyringePSN8db0facb-81b6-4006-9239-27dc6409c5d38
26047940.5 ML vutrisiran 50 MG/ML Prefilled Syringe [Amvuttra]SBD8db0facb-81b6-4006-9239-27dc6409c5d38
26047880.5 ML vutrisiran 50 MG/ML Prefilled SyringeSCD8db0facb-81b6-4006-9239-27dc6409c5d38
26047940.5 ML Amvuttra 50 MG/ML Prefilled SyringeSY8db0facb-81b6-4006-9239-27dc6409c5d38
2604794Amvuttra 25 MG per 0.5 ML Prefilled SyringeSY8db0facb-81b6-4006-9239-27dc6409c5d38
2604788vutrisiran 25 MG (as vutrisiran sodium 26.5 MG) per 0.5 ML Prefilled SyringeSY8db0facb-81b6-4006-9239-27dc6409c5d38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71336-1003-1713361003011 SYRINGE, GLASS in 1 CARTON (71336-1003-1) / .5 mL in 1 SYRINGE, GLASS2022-06-130000-00-00NoNoCurrent