Phenylephrine Hydrochloride

Product NDC
17478-201
11-digit product format
174780201
Labeler code
17478
Product ID
17478-201_2ad7940b-ea2c-46d2-86ae-bbf382cae5a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
NDA207926
Marketing category
NDA
Marketing start
2015-01-15
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-201-02ML - Milliliter17478-201a671fe1c-6b0d-4e8b-9768-eb20c2b7f2cb12015-03-03
17478-201-15ML - Milliliter17478-201b2380ddf-1518-4c45-84e2-e588ef1fb3d912015-03-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSN9cfafc70-6218-4de6-9351-cb08e6350e847
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCD9cfafc70-6218-4de6-9351-cb08e6350e847
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSY9cfafc70-6218-4de6-9351-cb08e6350e847

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17478-201-02174780201021 BOTTLE, DROPPER in 1 CARTON (17478-201-02) > 2 mL in 1 BOTTLE, DROPPER2015-01-150000-00-00NoNoCurrent
17478-201-15174780201151 BOTTLE, DROPPER in 1 CARTON (17478-201-15) > 15 mL in 1 BOTTLE, DROPPER2015-01-150000-00-00NoNoCurrent