FDA.reportPublic FDA data

PHENYLEPHRINE HYDROCHLORIDE

Product NDC
68083-593
11-digit product format
680830593
Labeler code
68083
Product ID
68083-593_b31e3905-8ee4-46db-ba72-358ea7d44f10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Gland Pharma Limited
Application
ANDA218129
Marketing category
ANDA
Marketing start
2024-12-18
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-593-01PHENYLEPHRINE HYDROCHLORIDE1 in 1 CARTONSOLUTION/ DROPS17
68083-593-01PHENYLEPHRINE HYDROCHLORIDE2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-593PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [GLAND PHARMA LIMITED]4Current NDC, 2 package rows20241222_2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSN2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSN2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCD2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCD2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSY2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSY2ba80bb2-24f3-4bce-bc04-a6ff4c54fefb7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-593-01680830593011 BOTTLE, DROPPER in 1 CARTON (68083-593-01) / 2 mL in 1 BOTTLE, DROPPER2024-12-18NoNoCurrent