Phenylephrine Hydrochloride

Product NDC
25021-315
11-digit product format
250210315
Labeler code
25021
Product ID
25021-315_045c8994-a54f-4b5c-8b70-7cf7c962a59f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA209967
Marketing category
ANDA
Marketing start
2020-10-15
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
25021-315-01Phenylephrine Hydrochloride25 in 1 CARTONINJECTION, SOLUTION251
25021-315-01Phenylephrine Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION11
25021-315-98Phenylephrine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION11
25021-315-98Phenylephrine Hydrochloride10 mL in 1 VIALINJECTION, SOLUTION101
25021-315-99Phenylephrine Hydrochloride5 mL in 1 VIALINJECTION, SOLUTION51
25021-315-99Phenylephrine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-315PHENYLEPHRINE HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, Legacy NDC, 6 package rows20201015_b3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYb3ff0d1d-6f3f-4e3c-9407-6f3bf3a61e7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-315-012502103150125 VIAL in 1 CARTON (25021-315-01) / 1 mL in 1 VIAL25 vial2020-10-150000-00-00NoNoCurrent
25021-315-98250210315981 VIAL in 1 CARTON (25021-315-98) / 10 mL in 1 VIAL1 vial2020-10-150000-00-00NoNoCurrent
25021-315-992502103159910 VIAL in 1 CARTON (25021-315-99) / 5 mL in 1 VIAL10 vial2020-10-150000-00-00NoNoCurrent