FDA.reportPublic FDA data

phenylephrine hydrochloride

Product NDC
68083-339
11-digit product format
680830339
Labeler code
68083
Product ID
68083-339_61b63c37-7fc9-4557-acf6-eea73b84b4c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA211920
Marketing category
ANDA
Marketing start
2020-10-21
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
68083-339-01phenylephrine hydrochloride10 mL in 1 VIALINJECTION108
68083-339-01phenylephrine hydrochloride1 in 1 CARTONINJECTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-339PHENYLEPHRINE HYDROCHLORIDE INJECTION PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE) INJECTION [GLAND PHARMA LIMITED]8Current NDC, Legacy NDC, 2 package rows20210415_6486d284-5189-4000-aa7d-67150e84a7b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN6486d284-5189-4000-aa7d-67150e84a7b28
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN6486d284-5189-4000-aa7d-67150e84a7b28
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD6486d284-5189-4000-aa7d-67150e84a7b28
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD6486d284-5189-4000-aa7d-67150e84a7b28
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY6486d284-5189-4000-aa7d-67150e84a7b28
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY6486d284-5189-4000-aa7d-67150e84a7b28
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY6486d284-5189-4000-aa7d-67150e84a7b28
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY6486d284-5189-4000-aa7d-67150e84a7b28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-339-01680830339011 VIAL in 1 CARTON (68083-339-01) / 10 mL in 1 VIAL1 vial2020-10-210000-00-00NoNoCurrent