FDA.reportPublic FDA data

TAKHZYRO

Product NDC
47783-646
11-digit product format
477830646
Labeler code
47783
Product ID
47783-646_143e1cd2-1b4f-4b78-bdbf-7ac83300e34c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lanadelumab-flyo
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA761090
Marketing category
BLA
Marketing start
2022-02-08
Substance
LANADELUMAB
Active strength
300 mg/2mL
Pharmacologic classes
Kallikrein Inhibitors [MoA], Plasma Kallikrein Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
1d6aad9b-2d3c-4fdf-9543-aa90c06d2f73Product name120181206
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47783-646-01TAKHZYRO2 mL in 1 SYRINGE, GLASSSOLUTION214
47783-646-01TAKHZYRO1 in 1 CARTONSOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47783-646-01ML - Milliliter47783-6463a2f0cdd-d311-4efd-bbfd-3b705e71c62e12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47783-646TAKHZYRO (LANADELUMAB-FLYO) SOLUTION TAKHZYRO (LANADELUMAB-FLYO) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Current NDC, Legacy NDC, 2 package rows20250312_15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2629980lanadelumab-flyo 150 MG in 1 ML Prefilled SyringePSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2055645lanadelumab-flyo 300 MG in 2 ML InjectionPSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593416lanadelumab-flyo 300 MG in 2 ML Prefilled SyringePSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2629981Takhzyro 150 MG in 1 ML Prefilled SyringePSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2055650TAKHZYRO 300 MG in 2 ML InjectionPSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593419Takhzyro 300 MG in 2 ML Prefilled SyringePSN15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
26299811 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]SBD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
20556502 ML lanadelumab-flyo 150 MG/ML Injection [Takhzyro]SBD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
25934192 ML lanadelumab-flyo 150 MG/ML Prefilled Syringe [Takhzyro]SBD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
26299801 ML lanadelumab-flyo 150 MG/ML Prefilled SyringeSCD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
20556452 ML lanadelumab-flyo 150 MG/ML InjectionSCD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
25934162 ML lanadelumab-flyo 150 MG/ML Prefilled SyringeSCD15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
20556502 ML Takhzyro 150 MG/ML InjectionSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2629980lanadelumab-flyo 150 MG per 1 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593416lanadelumab-flyo 150 MG/ML per 2 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2055645lanadelumab-flyo 300 MG per 2 ML InjectionSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593416lanadelumab-flyo 300 MG per 2 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2629981Takhzyro 150 MG per 1 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593419Takhzyro 150 MG/ML per 2 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2055650Takhzyro 300 MG per 2 ML InjectionSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814
2593419Takhzyro 300 MG per 2 ML Prefilled SyringeSY15f99d8c-efe7-4f7d-aa20-0d0f1e30c6e814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47783-646-01477830646011 SYRINGE, GLASS in 1 CARTON (47783-646-01) / 2 mL in 1 SYRINGE, GLASS2022-02-080000-00-00NoNoCurrent