FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
72603-530
11-digit product format
726030530
Labeler code
72603
Product ID
72603-530_0244964b-db1f-4208-b7e1-df2244566116
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
NorthStar RxLLC
Application
ANDA216496
Marketing category
ANDA
Marketing start
2024-10-01
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
100 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 HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ
Rxcui1234571

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
72603-530-01Phenylephrine Hydrochloride5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51
72603-530-01Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-530-01ML - Milliliter72603-5301b82d747-d045-4a60-a8a4-a398cc004bb412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-530PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [NORTHSTAR RXLLC]1Current NDC, 2 package rows20241001_ea70aafe-f3ba-471a-8c8f-f533c0a3c27c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSNea70aafe-f3ba-471a-8c8f-f533c0a3c27c1
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCDea70aafe-f3ba-471a-8c8f-f533c0a3c27c1
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSYea70aafe-f3ba-471a-8c8f-f533c0a3c27c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72603-530-01726030530011 BOTTLE, DROPPER in 1 CARTON (72603-530-01) / 5 mL in 1 BOTTLE, DROPPER2024-10-01NoNoCurrent