FDA.reportPublic FDA data

Phenylephrine hydrochloride

Product NDC
70121-1578
11-digit product format
701211578
Labeler code
70121
Product ID
70121-1578_51c93f70-2373-491c-b47e-24297a4c8266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA211078
Marketing category
ANDA
Marketing start
2018-07-24
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
70121-1578-1Phenylephrine hydrochloride5 mL in 1 VIAL, PHARMACY BULK PACKAGEINJECTION59
70121-1578-7Phenylephrine hydrochloride10 in 1 CARTONINJECTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1578-1ML - Milliliter70121-15783b014594-85a8-41cf-9883-a5eb908c827712019-02-13
70121-1578-7ML - Milliliter70121-15783fabb3ee-e689-468d-a1b9-870bc63dca9a12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1578PHENYLEPHRINE HYDROCHLORIDE INJECTION [AMNEAL PHARMACEUTICALS LLC]9Current NDC, Legacy NDC, 2 package rows20250315_a05a70b9-f506-456f-a7aa-d9f9c80a7f12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1232651phenylephrine HCl 10 MG/ML Injectable SolutionPSNa05a70b9-f506-456f-a7aa-d9f9c80a7f129
1232651phenylephrine hydrochloride 10 MG/ML Injectable SolutionSCDa05a70b9-f506-456f-a7aa-d9f9c80a7f129
1232651phenylephrine hydrochloride 1 % Injectable SolutionSYa05a70b9-f506-456f-a7aa-d9f9c80a7f129
1232651phenylephrine hydrochloride 100 MG per 10 ML Injectable SolutionSYa05a70b9-f506-456f-a7aa-d9f9c80a7f129
1232651phenylephrine hydrochloride 50 MG per 5 ML Injectable SolutionSYa05a70b9-f506-456f-a7aa-d9f9c80a7f129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1578-1701211578015 mL in 1 VIAL, PHARMACY BULK PACKAGE5 mlHistorical
70121-1578-77012115780710 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (70121-1578-7) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE (70121-1578-1) 2018-07-240000-00-00NoNoCurrent