Phenylephrine Hydrochloride

Product NDC
52584-577
11-digit product format
525840577
Labeler code
52584
Product ID
52584-577_1658e8d9-9ff7-48af-ab81-a0c1907449a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
General Injectables and Vaccines, Inc.
Application
ANDA211079
Marketing category
ANDA
Marketing start
2019-07-23
Marketing end
2023-04-30
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
10 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52584-577-01525840577011 VIAL, SINGLE-DOSE in 1 BAG (52584-577-01) > 1 mL in 1 VIAL, SINGLE-DOSE2019-07-232023-04-30NoNoCurrent