FDA.reportPublic FDA data

Phenylephrine hydrochloride

Product NDC
70756-621
11-digit product format
707560621
Labeler code
70756
Product ID
70756-621_3332dd2d-6f93-464d-b13e-f72c5496cd9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Lifestar Pharma LLC
Application
ANDA217069
Marketing category
ANDA
Marketing start
2022-08-31
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
70756-621-25Phenylephrine hydrochloride25 in 1 CARTONINJECTION254
70756-621-82Phenylephrine hydrochloride1 mL in 1 VIALINJECTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-621-25ML - Milliliter70756-621d76f5dc0-b94b-4987-9f66-a7b7621ae31612022-11-07
70756-621-82ML - Milliliter70756-621691d5bc1-a6ce-499b-ace7-a163e75b849812024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-621PHENYLEPHRINE HYDROCHLORIDE INJECTION [LIFESTAR PHARMA LLC]4Current NDC, Legacy NDC, 2 package rows20230330_4cea0781-2513-4030-8568-62dec253f866.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN4cea0781-2513-4030-8568-62dec253f8664
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN4cea0781-2513-4030-8568-62dec253f8664
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD4cea0781-2513-4030-8568-62dec253f8664
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD4cea0781-2513-4030-8568-62dec253f8664
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY4cea0781-2513-4030-8568-62dec253f8664
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY4cea0781-2513-4030-8568-62dec253f8664
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY4cea0781-2513-4030-8568-62dec253f8664
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY4cea0781-2513-4030-8568-62dec253f8664
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN386663e8-f1f6-cf14-e063-6394a90a68df3
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD386663e8-f1f6-cf14-e063-6394a90a68df3
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY386663e8-f1f6-cf14-e063-6394a90a68df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-621-257075606212525 VIAL in 1 CARTON (70756-621-25) / 1 mL in 1 VIAL (70756-621-82) 25 vial2022-08-310000-00-00NoNoCurrent
70756-621-82707560621821 mL in 1 VIAL1 mlHistorical