PHENYLEPHRINE HYDROCHLORIDE

Product NDC
72205-265
11-digit product format
722050265
Labeler code
72205
Product ID
72205-265_0bb7af81-62ec-4ae7-8055-89453f7a161d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Novadoz Pharmaceuticals LLC
Application
ANDA217521
Marketing category
ANDA
Marketing start
2023-07-10
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72205-265-01PHENYLEPHRINE HYDROCHLORIDE5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION51
72205-265-07PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72205-265-01ML - Milliliter72205-26500227242-2de8-4935-b181-9e317ce52a7012024-07-12
72205-265-07ML - Milliliter72205-2651a76969c-d04c-483d-8649-832fd5a68dee12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72205-265PHENYLEPHRINE HYDROCHLORIDE INJECTION [NOVADOZ PHARMACEUTICALS LLC]1Current NDC, 2 package rows20240507_0bb7af81-62ec-4ae7-8055-89453f7a161d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN0bb7af81-62ec-4ae7-8055-89453f7a161d1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD0bb7af81-62ec-4ae7-8055-89453f7a161d1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY0bb7af81-62ec-4ae7-8055-89453f7a161d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72205-265-01722050265015 mL in 1 VIAL, PHARMACY BULK PACKAGE5 mlHistorical
72205-265-077220502650710 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72205-265-07) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (72205-265-01) 2024-05-04NoNoCurrent