FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
71288-807
11-digit product format
712880807
Labeler code
71288
Product ID
71288-807_8c63c2aa-de67-4214-99bc-ba483b08d2b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA210334
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
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
71288-807-01PHENYLEPHRINE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION15
71288-807-02PHENYLEPHRINE HYDROCHLORIDE25 in 1 CARTONINJECTION255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-807-01ML - Milliliter71288-807d4b1a2ca-d325-4473-88a2-f2ca783414ce12020-06-05
71288-807-02ML - Milliliter71288-8074e505e46-b1a5-4d32-861a-dad0cba5687512020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-807PHENYLEPHRINE HYDROCHLORIDE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20230623_f2096e12-cbeb-4084-9132-17c7ef46b7b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNf2096e12-cbeb-4084-9132-17c7ef46b7b95
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDf2096e12-cbeb-4084-9132-17c7ef46b7b95
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYf2096e12-cbeb-4084-9132-17c7ef46b7b95
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSN4099cef4-44b1-ae3d-e063-6394a90aefac1
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCD4099cef4-44b1-ae3d-e063-6394a90aefac1
1666372phenylephrine HCl 10 MG per 1 ML InjectionSY4099cef4-44b1-ae3d-e063-6394a90aefac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-807-01712880807011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
71288-807-027128808070225 VIAL, SINGLE-DOSE in 1 CARTON (71288-807-02) / 1 mL in 1 VIAL, SINGLE-DOSE (71288-807-01) 2018-04-270000-00-00NoNoCurrent