Phenylephrine Hydrochloride

Product NDC
0404-9931
11-digit product format
004049931
Labeler code
0404
Product ID
0404-9931_a4ecb606-abf4-4f16-9c91-13d33831033c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA211079
Marketing category
ANDA
Marketing start
2022-01-13
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
Rxcui1666372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9931-99Phenylephrine Hydrochloride1 mL in 1 VIAL, SINGLE-DOSEINJECTION15
0404-9931-99Phenylephrine Hydrochloride1 in 1 BAGINJECTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9931PHENYLEPHRINE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.]4Current NDC, Legacy NDC, 2 package rows20240327_db313f72-a6bb-444f-949f-19b4aa6f61c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNdb313f72-a6bb-444f-949f-19b4aa6f61c05
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDdb313f72-a6bb-444f-949f-19b4aa6f61c05
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYdb313f72-a6bb-444f-949f-19b4aa6f61c05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9931-99004049931991 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99) / 1 mL in 1 VIAL, SINGLE-DOSE2022-01-130000-00-00NoNoCurrent