FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
55150-300
11-digit product format
551500300
Labeler code
55150
Product ID
55150-300_a816de08-7a48-43df-a09b-f1f342a230d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA210696
Marketing category
ANDA
Marketing start
2021-01-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenylephrine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1666372

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
55150-300-25Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION15
55150-300-25Phenylephrine Hydrochloride25 in 1 CARTONINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-300-01ML - Milliliter55150-30056cf2638-99d5-42ba-b2be-71bde181f92912021-03-02
55150-300-25ML - Milliliter55150-300dea50ef6-be42-491f-8cce-39c2758afa6112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-300PHENYLEPHRINE HYDROCHLORIDE INJECTION [EUGIA US LLC]4Current NDC, Legacy NDC, 2 package rows20240217_c2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNc2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc5
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDc2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc5
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYc2ba1b3e-94bc-494d-b0fe-4ab9dd61dddc5
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNd1639934-8aa6-2364-e053-2995a90a99232
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDd1639934-8aa6-2364-e053-2995a90a99232
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYd1639934-8aa6-2364-e053-2995a90a99232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-300-015515003000125 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-01) > 1 mL in 1 VIAL, SINGLE-DOSE2021-01-070000-00-00NoNoCurrent
55150-300-255515003002525 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25) / 1 mL in 1 VIAL, SINGLE-DOSE2021-01-070000-00-00NoNoCurrent