FDA.reportPublic FDA data

Phenylephrine hydrochloride

Product NDC
81284-212
11-digit product format
812840212
Labeler code
81284
Product ID
81284-212_9302b62e-3f80-4e5c-afa5-a775ed2c2ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Provepharm Inc.
Application
ANDA211081
Marketing category
ANDA
Marketing start
2020-08-12
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81284-212-00Phenylephrine hydrochloride5 mL in 1 VIALINJECTION56
81284-212-10Phenylephrine hydrochloride10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-212-00ML - Milliliter81284-2121faf0885-7fb0-49a7-9caa-04a07551861c12023-03-13
81284-212-10ML - Milliliter81284-212e93c1cf7-80be-46cf-8b01-02925717a43f12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-212PHENYLEPHRINE HYDROCHLORIDE INJECTION [PROVEPHARM INC.]5Current NDC, Legacy NDC, 2 package rows20241103_e1d3881f-fa9e-4d68-8ef0-9e03435fc292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYe1d3881f-fa9e-4d68-8ef0-9e03435fc2926
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYe1d3881f-fa9e-4d68-8ef0-9e03435fc2926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81284-212-00812840212005 mL in 1 VIAL5 mlHistorical
81284-212-108128402121010 VIAL in 1 CARTON (81284-212-10) / 5 mL in 1 VIAL (81284-212-00) 10 vial2020-08-120000-00-00NoNoCurrent