phenylephrine hydrochloride injection, solution

Product NDC
43598-182
11-digit product format
435980182
Labeler code
43598
Product ID
43598-182_933d3739-a253-94c4-c37e-7872f700ba79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenylephrine hydrochloride injection, solution
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA216830
Marketing category
NDA
Marketing start
2025-07-01
Substance
PHENYLEPHRINE
Active strength
80 ug/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
phenylephrine hydrochloride injection, solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE80 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1WS297W6MV
Rxcui2717659

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
43598-182-05phenylephrine hydrochloride injection, solution5 in 1 CARTONINJECTION, SOLUTION53
43598-182-50phenylephrine hydrochloride injection, solution250 mL in 1 BAGINJECTION, SOLUTION2503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-182-05ML - Milliliter43598-182bfa07b5c-500e-4e30-8fb6-6cbc2546064212026-01-08
43598-182-50ML - Milliliter43598-1823a415a8d-8c21-42ea-9d8d-67807817e2f312026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717659phenylephrine hydrochloride 20 MG in 250 ML InjectionPSN71b8fb8a-e13a-246f-f7b4-aa912b9ccd543
2717659250 ML phenylephrine hydrochloride 0.08 MG/ML InjectionSCD71b8fb8a-e13a-246f-f7b4-aa912b9ccd543
2717659phenylephrine hydrochloride 0.08 MG/ML per 250 ML InjectionSY71b8fb8a-e13a-246f-f7b4-aa912b9ccd543
2717659phenylephrine hydrochloride 20 MG (phenylephrine 16.4 MG) per 250 ML InjectionSY71b8fb8a-e13a-246f-f7b4-aa912b9ccd543
2717659phenylephrine hydrochloride 20 MG per 250 ML InjectionSY71b8fb8a-e13a-246f-f7b4-aa912b9ccd543

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-182-05435980182055 BAG in 1 CARTON (43598-182-05) / 250 mL in 1 BAG (43598-182-50) 5 bag2025-07-01NoNoHistorical
43598-182-5043598018250250 mL in 1 BAG250 mlHistorical