Phenylephrine Hydrochloride

Product NDC
70756-676
11-digit product format
707560676
Labeler code
70756
Product ID
70756-676_b19ab20c-5138-461a-adff-c5173046256c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA216859
Marketing category
ANDA
Marketing start
2025-08-26
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
Rxcui1234579

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70756-676-30Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS112
70756-676-30Phenylephrine Hydrochloride10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSNf43e4abd-0083-4fe5-9c27-0ba9245e513812
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCDf43e4abd-0083-4fe5-9c27-0ba9245e513812
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSYf43e4abd-0083-4fe5-9c27-0ba9245e513812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70756-676-30707560676301 BOTTLE, DROPPER in 1 CARTON (70756-676-30) / 10 mL in 1 BOTTLE, DROPPER2025-08-26NoNoCurrent