FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
14335-441
11-digit product format
143350441
Labeler code
14335
Product ID
14335-441_13fdb0eb-d8cb-ffd6-e063-6394a90a45ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hainan Poly Pharm. Co., Ltd.
Application
ANDA218412
Marketing category
ANDA
Marketing start
2024-03-19
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

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
14335-441-01Phenylephrine Hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION51
14335-441-01Phenylephrine Hydrochloride10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14335-441PHENYLEPHRINE HYDROCHLORIDE INJECTION [HAINAN POLY PHARM. CO., LTD.]1Current NDC, 2 package rows20240320_8d6973c4-4a69-4d49-9da7-d2a00df83ecb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY8d6973c4-4a69-4d49-9da7-d2a00df83ecb1
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY8d6973c4-4a69-4d49-9da7-d2a00df83ecb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
14335-441-011433504410110 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (14335-441-01) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE2024-03-19NoNoHistorical