FDA.reportPublic FDA data

Biorphen

Product NDC
71863-202
11-digit product format
718630202
Labeler code
71863
Product ID
71863-202_3508aaf0-b0e3-4aeb-909d-83c13c30a30f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eton Pharmaceuticals, Inc.
Application
NDA212909
Marketing category
NDA
Marketing start
2019-11-15
Marketing end
0000-00-00
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
0 mg/mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71863-202-062022-08-29C16284748780-1e4f33bdf-a71f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use BIORPHEN ® safely and effectively. See full prescribing information for BIORPHEN. BIORPHEN (phenylephrine hydrochloride) injection, for intravenous use Initial U.S. Approval: 1954
71863-202-062022-07-29C16284748780-1e4f33bdf-a71f-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use BIORPHEN ® safely and effectively. See full prescribing information for BIORPHEN. BIORPHEN (phenylephrine hydrochloride) injection, for intravenous use Initial U.S. Approval: 1954

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71863-202-05Biorphen5 mL in 1 AMPULEINJECTION, SOLUTION511
71863-202-06Biorphen10 in 1 CARTONINJECTION, SOLUTION1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71863-202-05ML - Milliliter71863-202c10d68dc-c825-419f-b0af-c41b108a50d712019-12-10
71863-202-06ML - Milliliter71863-202137b9806-5252-43af-ad25-73860295625712019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71863-202BIORPHEN (PHENYLEPHRINE HYDROCHLORIDE) INJECTION, SOLUTION [ETON PHARMACEUTICALS, INC.]11Legacy NDC, 2 package rows20220831_bf7daa65-2a6c-4d59-a6f3-3af70edcc7e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2533437Biorphen 10 MG in 1 ML InjectionPSNbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2533434Biorphen 500 MCG in 5 mL InjectionPSNbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
1666372phenylephrine HCl 10 MG in 1 ML InjectionPSNbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2262018phenylephrine hydrochloride 500 MCG in 5 mL InjectionPSNbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
25334371 ML phenylephrine hydrochloride 10 MG/ML Injection [Biorphen]SBDbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
25334345 ML phenylephrine hydrochloride 0.1 MG/ML Injection [Biorphen]SBDbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
16663721 ML phenylephrine hydrochloride 10 MG/ML InjectionSCDbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
22620185 ML phenylephrine hydrochloride 0.1 MG/ML InjectionSCDbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2533434Biorphen 0.1 MG/ML per 5 ML InjectionSYbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2533437Biorphen 10 MG per 1 ML InjectionSYbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2533434Biorphen 500 MCG per 5 ML InjectionSYbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
1666372phenylephrine HCl 10 MG per 1 ML InjectionSYbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211
2262018phenylephrine hydrochloride 500 MCG per 5 ML InjectionSYbf7daa65-2a6c-4d59-a6f3-3af70edcc7e211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71863-202-05718630202055 mL in 1 AMPULE5 mlHistorical
71863-202-067186302020610 AMPULE in 1 CARTON (71863-202-06) > 5 mL in 1 AMPULE (71863-202-05) 10 ampule2019-11-150000-00-00NoNoCurrent