FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
70756-649
11-digit product format
707560649
Labeler code
70756
Product ID
70756-649_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
2023-03-15
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
70756-649-35Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS112
70756-649-35Phenylephrine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-649-35ML - Milliliter70756-649bbe4f844-86b9-44f0-a312-38a6b12eb67912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-649PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [LIFESTAR PHARMA LLC]11Current NDC, 2 package rows20250119_f43e4abd-0083-4fe5-9c27-0ba9245e5138.zip

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
70756-649-35707560649351 BOTTLE, DROPPER in 1 CARTON (70756-649-35) / 15 mL in 1 BOTTLE, DROPPER2023-03-15NoNoCurrent