Phenylephrine hydrochloride

Product NDC
42023-214
11-digit product format
420230214
Labeler code
42023
Product ID
42023-214_e3034d8d-c47d-4ef2-aa1b-97953b1f3036
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
ANDA210025
Marketing category
ANDA
Marketing start
2019-07-17
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
Rxcui1232651

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-214-10Phenylephrine hydrochloride10 in 1 CARTONINJECTION1015
42023-214-10Phenylephrine hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-214-10ML - Milliliter42023-214b6587dd1-ccc6-49df-9ea7-397ebd479b9112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-214PHENYLEPHRINE HYDROCHLORIDE INJECTION [ENDO USA, INC.]11Current NDC, Legacy NDC, 2 package rows20240913_d92631a6-bae8-493b-b4df-c563346607a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNd92631a6-bae8-493b-b4df-c563346607a815
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDd92631a6-bae8-493b-b4df-c563346607a815
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYd92631a6-bae8-493b-b4df-c563346607a815
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYd92631a6-bae8-493b-b4df-c563346607a815
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYd92631a6-bae8-493b-b4df-c563346607a815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42023-214-104202302141010 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (42023-214-10) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE2019-07-170000-00-00NoNoCurrent