FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
71288-808
11-digit product format
712880808
Labeler code
71288
Product ID
71288-808_80aeb2e2-c42c-454b-a2da-880b0ff9319d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA210333
Marketing category
ANDA
Marketing start
2018-04-27
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

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
71288-808-75PHENYLEPHRINE HYDROCHLORIDE5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION53
71288-808-76PHENYLEPHRINE HYDROCHLORIDE10 in 1 CARTONINJECTION103
71288-808-77PHENYLEPHRINE HYDROCHLORIDE10 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION103
71288-808-77PHENYLEPHRINE HYDROCHLORIDE1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-808-75ML - Milliliter71288-80890b84b36-e93e-41f3-894a-83abff21d26412020-06-05
71288-808-76ML - Milliliter71288-8085b580c57-639e-4ec3-a9e2-67536c67ba6412020-06-05
71288-808-77ML - Milliliter71288-80893f570ab-4073-4e23-84c3-276b10c2358a12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-808PHENYLEPHRINE HYDROCHLORIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 4 package rows20201210_943638b7-527b-4724-a6b7-2018862396d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSN943638b7-527b-4724-a6b7-2018862396d43
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCD943638b7-527b-4724-a6b7-2018862396d43
1232651phenylephrine hydrochloride 1 % Injectable SolutionSY943638b7-527b-4724-a6b7-2018862396d43
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSY943638b7-527b-4724-a6b7-2018862396d43
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSY943638b7-527b-4724-a6b7-2018862396d43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-808-75712880808755 mL in 1 VIAL, PHARMACY BULK PACKAGE5 mlHistorical
71288-808-767128808087610 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-76) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (71288-808-75) 2018-04-270000-00-00NoNoCurrent
71288-808-77712880808771 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (71288-808-77) / 10 mL in 1 VIAL, PHARMACY BULK PACKAGE2018-04-270000-00-00NoNoCurrent