FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
69315-323
11-digit product format
693150323
Labeler code
69315
Product ID
69315-323_a73191de-c6e0-455f-8e26-f90a529cac56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Leading Pharma, LLC
Application
ANDA215183
Marketing category
ANDA
Marketing start
2024-09-05
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
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 HYDROCHLORIDE25 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1234571, 1234579

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
69315-323-08PHENYLEPHRINE HYDROCHLORIDE1 in 1 CARTONSOLUTION11
69315-323-08PHENYLEPHRINE HYDROCHLORIDE2 mL in 1 BOTTLE, DROPPERSOLUTION21
69315-323-15PHENYLEPHRINE HYDROCHLORIDE15 mL in 1 BOTTLE, DROPPERSOLUTION151
69315-323-15PHENYLEPHRINE HYDROCHLORIDE1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-323-08ML - Milliliter69315-32353d321c4-050e-472e-a1fc-4d204fac530412024-10-04
69315-323-15ML - Milliliter69315-3233e23c429-42bd-4a41-a842-cff522259fc712024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-323PHENYLEPHRINE HYDROCHLORIDE SOLUTION [LEADING PHARMA, LLC]1Current NDC, 4 package rows20240906_7543f7e8-fd5f-46d5-a310-ebae71becf44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSN7543f7e8-fd5f-46d5-a310-ebae71becf441
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSN7543f7e8-fd5f-46d5-a310-ebae71becf441
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCD7543f7e8-fd5f-46d5-a310-ebae71becf441
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCD7543f7e8-fd5f-46d5-a310-ebae71becf441
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSY7543f7e8-fd5f-46d5-a310-ebae71becf441
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSY7543f7e8-fd5f-46d5-a310-ebae71becf441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69315-323-08693150323081 BOTTLE, DROPPER in 1 CARTON (69315-323-08) / 2 mL in 1 BOTTLE, DROPPER2024-09-05NoNoCurrent
69315-323-15693150323151 BOTTLE, DROPPER in 1 CARTON (69315-323-15) / 15 mL in 1 BOTTLE, DROPPER2024-09-05NoNoCurrent