Vyleesi

Product NDC
64011-701
11-digit product format
640110701
Labeler code
64011
Product ID
64011-701_ae24b6c4-e9c0-4108-89f2-3b2ba4166b49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bremelanotide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
AMAG Pharmaceuticals, Inc.
Application
NDA210557
Marketing category
NDA
Marketing start
2019-06-21
Marketing end
0000-00-00
Substance
BREMELANOTIDE ACETATE
Active strength
2 mg/.3mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64011-701-01ML - Milliliter64011-7018ac1b9ac-145c-475b-8693-e8b71fd6e44312019-09-05
64011-701-04ML - Milliliter64011-701f5e3c99a-ddd0-4034-8c0d-70a84cb1daa112019-09-05
64011-701-12ML - Milliliter64011-701f4ef2ac6-c558-4cc0-a5d1-6e8c7fd71d4412021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64011-701-04640110701044 SYRINGE in 1 CARTON (64011-701-04) > .3 mL in 1 SYRINGE (64011-701-01) 4 syringe2019-06-210000-00-00NoNoCurrent
64011-701-12640110701122 SYRINGE in 1 CARTON (64011-701-12) > .3 mL in 1 SYRINGE (64011-701-01) 2 syringe2019-09-090000-00-00NoNoCurrent