FDA.reportPublic FDA data

Phenylephrine Hydrochloride

Product NDC
70512-865
11-digit product format
705120865
Labeler code
70512
Product ID
70512-865_45728b25-194d-ddeb-e063-6294a90af4c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA215183
Marketing category
ANDA
Marketing start
2024-06-01
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
70512-865-02Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS13
70512-865-02Phenylephrine Hydrochloride2 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS23
70512-865-15Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS13
70512-865-15Phenylephrine Hydrochloride15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-865-02ML - Milliliter70512-865cb56bd8e-a601-4cd0-bd21-d18abb0716a612024-07-12
70512-865-15ML - Milliliter70512-8652876bc89-8e9b-4e98-98f3-11ac9eea667312024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-865PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [SOLA PHARMACEUTICALS, LLC]2Current NDC, 4 package rows20240601_bf264b20-6d00-495e-90c7-9172d4535ec7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSNbf264b20-6d00-495e-90c7-9172d4535ec73
1234579phenylephrine HCl 2.5 % Ophthalmic SolutionPSNbf264b20-6d00-495e-90c7-9172d4535ec73
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCDbf264b20-6d00-495e-90c7-9172d4535ec73
1234579phenylephrine hydrochloride 25 MG/ML Ophthalmic SolutionSCDbf264b20-6d00-495e-90c7-9172d4535ec73
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSYbf264b20-6d00-495e-90c7-9172d4535ec73
1234579phenylephrine hydrochloride 2.5 % Ophthalmic SolutionSYbf264b20-6d00-495e-90c7-9172d4535ec73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70512-865-02705120865021 BOTTLE, DROPPER in 1 CARTON (70512-865-02) / 2 mL in 1 BOTTLE, DROPPER2024-06-01NoNoCurrent
70512-865-15705120865151 BOTTLE, DROPPER in 1 CARTON (70512-865-15) / 15 mL in 1 BOTTLE, DROPPER2024-06-01NoNoCurrent