FDA.reportPublic FDA data

Onpattro

Product NDC
71336-1000
11-digit product format
713361000
Labeler code
71336
Product ID
71336-1000_254d330d-6f47-45c4-9774-95864ab46941
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
patisiran
Dosage form
INJECTION, LIPID COMPLEX
Route
INTRAVENOUS
Labeler
Alnylam Pharmaceuticals, Inc.
Application
NDA210922
Marketing category
NDA
Marketing start
2018-08-13
Substance
PATISIRAN SODIUM
Active strength
2 mg/mL
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
Onpattro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PATISIRAN SODIUM2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWO0YM16LKG
Rxcui2053524, 2053529

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
a6d90113-5421-4bcb-a4b9-00a02e9efe4dProduct name120181029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71336-1000-1Onpattro1 in 1 CARTONINJECTION, LIPID COMPLEX111
71336-1000-1Onpattro5 mL in 1 VIAL, SINGLE-DOSEINJECTION, LIPID COMPLEX511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71336-1000-1ML - Milliliter71336-1000b9deef9a-3d35-414a-b5ae-98383951ea4212018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71336-1000ONPATTRO (PATISIRAN) INJECTION, LIPID COMPLEX [ALNYLAM PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20230126_e87ec36f-b4b4-49d4-aea4-d4ffb09b0970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2053529onpattro 10 MG in 5 ML InjectionPSNe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
2053524patisiran lipid complex 10 MG in 5 mL InjectionPSNe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
20535295 ML patisiran lipid complex 2 MG/ML Injection [Onpattro]SBDe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
20535245 ML patisiran lipid complex 2 MG/ML InjectionSCDe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
20535295 ML Onpattro 2 MG/ML InjectionSYe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
2053529Onpattro 10 MG per 5 ML InjectionSYe87ec36f-b4b4-49d4-aea4-d4ffb09b097011
2053524patisiran lipid complex 10 MG per 5 ML InjectionSYe87ec36f-b4b4-49d4-aea4-d4ffb09b097011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71336-1000-1713361000011 VIAL, SINGLE-DOSE in 1 CARTON (71336-1000-1) / 5 mL in 1 VIAL, SINGLE-DOSE2018-08-130000-00-00NoNoCurrent