FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
31722-345
11-digit product format
317220345
Labeler code
31722
Product ID
31722-345_23a5b85f-4414-6b2b-e063-6394a90aee77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA218110
Marketing category
ANDA
Marketing start
2024-05-10
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
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
31722-345-10PHENYLEPHRINE HYDROCHLORIDE10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION101
31722-345-10PHENYLEPHRINE HYDROCHLORIDE1 in 1 CARTONINJECTION11
31722-345-31PHENYLEPHRINE HYDROCHLORIDE10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION101
31722-345-31PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-345-10ML - Milliliter31722-345f60be141-3971-4851-a32b-52dbf3d4f86f12025-05-14
31722-345-31ML - Milliliter31722-345a479cdba-0cd4-4213-bb57-ea2abe70516312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-345PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 4 package rows20241006_744da574-dfc9-4a22-8983-2ee15be2ea84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN744da574-dfc9-4a22-8983-2ee15be2ea841
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN744da574-dfc9-4a22-8983-2ee15be2ea841
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD744da574-dfc9-4a22-8983-2ee15be2ea841
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD744da574-dfc9-4a22-8983-2ee15be2ea841
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY744da574-dfc9-4a22-8983-2ee15be2ea841
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY744da574-dfc9-4a22-8983-2ee15be2ea841
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY744da574-dfc9-4a22-8983-2ee15be2ea841
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY744da574-dfc9-4a22-8983-2ee15be2ea841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-345-10317220345101 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-10) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE2024-05-10NoNoCurrent
31722-345-313172203453110 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (31722-345-31) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE2024-05-10NoNoCurrent