Kynamro

Product NDC
70688-0502
11-digit product format
706880502
Labeler code
70688
Product ID
70688-0502_900bb03a-deb5-4522-8dc1-755994b073b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MIPOMERSEN SODIUM
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Kastle Therapeutics, LLC
Application
NDA203568
Marketing category
NDA
Marketing start
2016-05-02
Marketing end
0000-00-00
Substance
MIPOMERSEN SODIUM
Active strength
200 mg/mL
Pharmacologic classes
Apolipoprotein B-100 Synthesis Inhibitor [EPC],Decreased Protein Synthesis [PE],Antisense Oligonucleotide [EPC],Oligonucleotides, Antisense [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70688-0502-12020-01-31C16284748780-19d75b9d0-5506-f424-e053-dadaa90a57ce774c7847-490b-41d5-9e0e-2baedbc94f62
70688-0502-22020-01-31C16284748780-19d75b9d0-5506-f424-e053-dadaa90a57ce774c7847-490b-41d5-9e0e-2baedbc94f62

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70688-0502-1Kynamro1 in 1 CARTONINJECTION, SOLUTION12
70688-0502-1Kynamro1 mL in 1 SYRINGEINJECTION, SOLUTION12
70688-0502-2Kynamro1 mL in 1 SYRINGEINJECTION, SOLUTION12
70688-0502-2Kynamro4 in 1 CARTONINJECTION, SOLUTION42

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70688-0502-1ML - Milliliter70688-0502b6292344-0bb0-4f72-ab7e-20684faf21dd12017-03-06
70688-0502-2ML - Milliliter70688-0502151fed5b-1c09-4237-aaba-23fcfae79b5c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70688-0502KYNAMRO (MIPOMERSEN SODIUM) INJECTION, SOLUTION [KASTLE THERAPEUTICS, LLC]2Legacy NDC, 4 package rows20170217_774c7847-490b-41d5-9e0e-2baedbc94f62.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367848Kynamro 200 MG in 1 ML Prefilled SyringePSN774c7847-490b-41d5-9e0e-2baedbc94f622
1367843mipomersen sodium 200 MG in 1 ML Prefilled SyringePSN774c7847-490b-41d5-9e0e-2baedbc94f622
13678481 ML mipomersen sodium 200 MG/ML Prefilled Syringe [Kynamro]SBD774c7847-490b-41d5-9e0e-2baedbc94f622
13678431 ML mipomersen sodium 200 MG/ML Prefilled SyringeSCD774c7847-490b-41d5-9e0e-2baedbc94f622
13678481 ML Kynamro 200 MG/ML Prefilled SyringeSY774c7847-490b-41d5-9e0e-2baedbc94f622
1367848Kynamro 200 MG/ML 1 ML Prefilled SyringeSY774c7847-490b-41d5-9e0e-2baedbc94f622
1367843mipomersen sodium 200 MG per 1 ML Prefilled SyringeSY774c7847-490b-41d5-9e0e-2baedbc94f622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70688-0502-1706880502011 in 1 CARTONHistorical
70688-0502-2706880502021 mL in 1 SYRINGE1 mlHistorical