IMMPHENTIV

Product NDC
0641-6245
11-digit product format
006416245
Labeler code
0641
Product ID
0641-6245_f73e455e-cbfa-48af-b4ce-505de8e8f761
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA203826
Marketing category
NDA
Marketing start
2023-03-09
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 ug/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE61-76-7PHENYLEPHRINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6245-100064162451010 VIAL in 1 CARTON (0641-6245-10) / 5 mL in 1 VIAL10 vial2023-03-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Phenylephrine HydrochlorideHikma Pharmaceuticals USA Inc.2024-04-09HUMAN PRESCRIPTION DRUG LABEL12