FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
0641-6142
11-digit product format
006416142
Labeler code
0641
Product ID
0641-6142_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
2012-12-18
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, 1666372, 2262018, 2634228, 2634233, 2634235

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
0641-6142-01Phenylephrine Hydrochloride1 mL in 1 VIALINJECTION112
0641-6142-25Phenylephrine Hydrochloride25 in 1 CARTONINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6142-01ML - Milliliter0641-61422163e7a3-7bd4-48f6-8efb-d3b2a136e89e12013-03-03
0641-6142-25ML - Milliliter0641-614268bfdb02-41e9-4ce8-9c3f-7d4c4b6b5f5512013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6
WATERINACTIVE INGREDIENT059QF0KO0RPHENYLEPHRINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6142PHENYLEPHRINE HYDROCHLORIDE INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTION IMMPHENTIV (PHENYLEPHRINE HYDROCHLORIDE) INJECTABLE, LIPOSOMAL [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20240410_e1a7ab4b-0afe-4463-a039-5be0323cf2f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634233IMMPHENTIV 1000 MCG in 10 ML InjectionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634235IMMPHENTIV 500 MCG in 5 ML InjectionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634228phenylephrine hydrochloride 1000 MCG in 10 ML InjectionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2262018phenylephrine hydrochloride 500 MCG in 5 mL InjectionPSNe1a7ab4b-0afe-4463-a039-5be0323cf2f712
263423310 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv]SBDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
26342355 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Immphentiv]SBDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
263422810 ML phenylephrine hydrochloride 0.1 MG/ML InjectionSCDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
22620185 ML phenylephrine hydrochloride 0.1 MG/ML InjectionSCDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634233Immphentiv 0.1 MG/ML per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634235Immphentiv 0.1 MG/ML per 5 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634235Immphentiv 0.5 MG per 5 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634233Immphentiv 1 MG per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634233Immphentiv 1000 MCG per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634235Immphentiv 500 MCG per 5 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634228phenylephrine hydrochloride 0.1 MG/ML per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634228phenylephrine hydrochloride 1 MG per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2634228phenylephrine hydrochloride 1000 MCG per 10 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
2262018phenylephrine hydrochloride 500 MCG per 5 ML InjectionSYe1a7ab4b-0afe-4463-a039-5be0323cf2f712
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN7602fb73-3ce3-5978-e053-2991aa0abea38
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD7602fb73-3ce3-5978-e053-2991aa0abea38
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY7602fb73-3ce3-5978-e053-2991aa0abea38
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNd88a01c4-9681-2695-e053-2995a90a62ea2
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDd88a01c4-9681-2695-e053-2995a90a62ea2
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYd88a01c4-9681-2695-e053-2995a90a62ea2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6142-01006416142011 mL in 1 VIAL1 mlHistorical
0641-6142-250064161422525 VIAL in 1 CARTON (0641-6142-25) / 1 mL in 1 VIAL (0641-6142-01) 25 vial2012-12-180000-00-00NoNoCurrent