Phenylephrine Hydrochloride

Product NDC
70756-614
11-digit product format
707560614
Labeler code
70756
Product ID
70756-614_142b8516-38b4-4b3b-938a-39ca65c17bdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Lifestar Pharma LLC
Application
ANDA216496
Marketing category
ANDA
Marketing start
2023-01-18
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
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
70756-614-30Phenylephrine Hydrochloride5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS55
70756-614-30Phenylephrine Hydrochloride1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-614-30ML - Milliliter70756-6149088007f-32ea-4b74-9493-d4d9748ad4ca12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-614PHENYLEPHRINE HYDROCHLORIDE SOLUTION/ DROPS [LIFESTAR PHARMA LLC]5Current NDC, Legacy NDC, 2 package rows20230520_1767c4b7-36a0-4e64-9091-2af22161402f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234571phenylephrine HCl 10 % Ophthalmic SolutionPSN1767c4b7-36a0-4e64-9091-2af22161402f5
1234571phenylephrine hydrochloride 100 MG/ML Ophthalmic SolutionSCD1767c4b7-36a0-4e64-9091-2af22161402f5
1234571phenylephrine hydrochloride 10 % Ophthalmic SolutionSY1767c4b7-36a0-4e64-9091-2af22161402f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70756-614-30707560614301 BOTTLE, DROPPER in 1 CARTON (70756-614-30) / 5 mL in 1 BOTTLE, DROPPER2023-01-180000-00-00NoNoCurrent