FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
55150-301
11-digit product format
551500301
Labeler code
55150
Product ID
55150-301_83623537-573d-40fc-8a40-e6beabf72c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA210697
Marketing category
ANDA
Marketing start
2020-11-13
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PHENYLEPHRINE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1232651

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-301-01PHENYLEPHRINE HYDROCHLORIDE5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION53
55150-301-10PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-301-01ML - Milliliter55150-301c7891fe9-6bd0-49f0-a11b-96d03dd005e112021-02-05
55150-301-10ML - Milliliter55150-301e6857093-ea88-4392-a4f7-43ff1c9f23cb12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-301PHENYLEPHRINE HYDROCHLORIDE INJECTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20230917_303bc1e6-0735-4ea1-84cd-6c1b621de0ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN303bc1e6-0735-4ea1-84cd-6c1b621de0ed3
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD303bc1e6-0735-4ea1-84cd-6c1b621de0ed3
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY303bc1e6-0735-4ea1-84cd-6c1b621de0ed3
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY303bc1e6-0735-4ea1-84cd-6c1b621de0ed3
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY303bc1e6-0735-4ea1-84cd-6c1b621de0ed3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55150-301-01551500301015 mL in 1 VIAL, PHARMACY BULK PACKAGE5 mlHistorical
55150-301-105515003011010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (55150-301-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (55150-301-01) 2020-11-130000-00-00NoNoCurrent