FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
70594-064
11-digit product format
705940064
Labeler code
70594
Product ID
70594-064_69ee5794-96b0-4975-aadd-d8dbcc73ca3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA213318
Marketing category
ANDA
Marketing start
2022-01-01
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
50 mg/5mL
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 HYDROCHLORIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1232651, 1666372

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
70594-064-01Phenylephrine Hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION51
70594-064-02Phenylephrine Hydrochloride10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-064PHENYLEPHRINE HYDROCHLORIDE INJECTION [XELLIA PHARMACEUTICALS USA LLC]1Current NDC, Legacy NDC, 2 package rows20220302_abd39d9c-fcda-4d01-8a58-1d54ba7ac651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYabd39d9c-fcda-4d01-8a58-1d54ba7ac6511
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYabd39d9c-fcda-4d01-8a58-1d54ba7ac6511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-064-01705940064015 mL in 1 VIAL, PHARMACY BULK PACKAGE5 mlHistorical
70594-064-027059400640210 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70594-064-02) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70594-064-01) 2022-01-010000-00-00NoNoCurrent