Vazculep

Product NDC
51754-4000
11-digit product format
517544000
Labeler code
51754
Product ID
51754-4000_e457de4e-3de8-4cb9-9c1b-5e0ff5630f5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Exela Phrama Sciences, LLC
Application
NDA204300
Marketing category
NDA
Marketing start
2021-03-26
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-4000-3ML - Milliliter51754-4000fb4f699c-109d-4681-859d-614b9374b1e912021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-4000VAZCULEP (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [EXELA PHRAMA SCIENCES, LLC]1Legacy NDC20210326_c73fc68d-6a3d-4d99-8869-cc64d7c6bf94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51754-4000-3517544000031 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (51754-4000-3) > 5 mL in 1 VIAL, PHARMACY BULK PACKAGE2021-03-260000-00-00NoNoCurrent