PHENYLEPHRINE HYDROCHLORIDE

Product NDC
51662-1576
11-digit product format
516621576
Labeler code
51662
Product ID
51662-1576_11fff86b-b35b-a576-e063-6394a90a1fa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA210665
Marketing category
ANDA
Marketing start
2021-06-30
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 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
51662-1576-1PHENYLEPHRINE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION14
51662-1576-2PHENYLEPHRINE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION14
51662-1576-2PHENYLEPHRINE HYDROCHLORIDE1 in 1 POUCHINJECTION14
51662-1576-3PHENYLEPHRINE HYDROCHLORIDE25 in 1 CASEINJECTION254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1576PHENYLEPHRINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 4 package rows20240224_c600fe14-40b6-2b5a-e053-2a95a90aff98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNc600fe14-40b6-2b5a-e053-2a95a90aff984
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDc600fe14-40b6-2b5a-e053-2a95a90aff984
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYc600fe14-40b6-2b5a-e053-2a95a90aff984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1576-1516621576011 mL in 1 VIAL, SINGLE-DOSE (51662-1576-1) 1 ml2021-06-300000-00-00NoNoCurrent
51662-1576-2516621576021 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
51662-1576-35166215760325 POUCH in 1 CASE (51662-1576-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1576-2) / 1 mL in 1 VIAL, SINGLE-DOSE25 pouch2022-07-100000-00-00NoNoCurrent