Phenylephrine Injection

Brand(s)
Neo-Synephrine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2014-06-03)
Oldest Current Product
1990-09-30
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTION\PHENYLEPHRINE
FDAOB
IV (INFUSION)\SOLUTION\PHENYLEPHRINE HYDROCHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYLEPHRINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\PHENYLEPHRINE HYDROCHLORIDE
INTRAVENOUS\INJECTION\PHENYLEPHRINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\PHENYLEPHRINE
INTRAMUSCULAR\INJECTION\PHENYLEPHRINE
INTRAVENOUS\INJECTION\PHENYLEPHRINE

product(s) by strength(s)

1 ml phenylephrine hydrochloride 10 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006416142NDAWest-Ward Pharmaceuticals Corp.2012-12-18PHENYLEPHRINE HYDROCHLORIDEINTRAVENOUSINJECTIONNDA203826e1a7ab4b-0afe-4463-a039-5be0323cf2f7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840016UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION100190163b6d3c9af-53f7-4c14-8608-f41a3ef9894d
2525840142NDAGeneral Injecatables & Vaccines, Inc2013-04-02PHENYLEPHRINE HYDROCHLORIDEINTRAVENOUSINJECTION006416142NDA20382646c75ffd-d03a-420e-ae71-10ffffd94321
3525840299UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2012-01-25PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION0051702994256b3c7-23c5-4743-a311-916cee1de1c1
4525840800Neo-SynephrineUNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION00409180009f988b2-e313-4568-964e-fe1f23ab2b59
5551542852UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health2010-04-09PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION100190163bc7981a2-b950-4e27-9aef-a3f6d2d39039
6551545128NDACardinal Health2012-12-20PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION006416088NDA2038267dfaac8d-ceab-4af0-9c44-bed73414789d
7551545735UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1990-09-30PHENYLEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION0051702997ded7d58-56c3-41e3-94b1-a6bba34a91f0

application(s)

#idtitleapplicantapprovedapproved drug
1NDA203826PHENYLEPHRINE HYDROCHLORIDEWEST WARD PHARMACEUTICAL CORP2012-12-20NDA203826_001
2NDA204300VAZCULEPECLAT PHARMACEUTICALS LLC2014-06-27NDA204300_001, NDA204300_002, NDA204300_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA203826_001RXPHENYLEPHRINE HYDROCHLORIDE (10MG/ML)SOLUTIONTrue2012-12-20PHENYLEPHRINE HYDROCHLORIDE
2NDA204300_001RXPHENYLEPHRINE HYDROCHLORIDE (10MG/ML)SOLUTIONFalse2014-06-27VAZCULEP
3NDA204300_002RXPHENYLEPHRINE HYDROCHLORIDE (50MG/5ML)SOLUTIONFalse2014-06-27VAZCULEP
4NDA204300_003RXPHENYLEPHRINE HYDROCHLORIDE (100MG/10ML)SOLUTIONTrue2014-06-27VAZCULEP

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109f988b2-e313-4568-964e-fe1f23ab2b59 (view SPL)Neo-Synephrine HCL (Phenylephrine Hydrochloride) 10 mg/mL Injection, USP 1 mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-311525840800
24256b3c7-23c5-4743-a311-916cee1de1c1 (view SPL)Phenylephrine Hydrochloride 1% 10mg/mL SDVprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-01-251525840299
346c75ffd-d03a-420e-ae71-10ffffd94321 (view SPL)Phenylephrine HCL Injection, USPRx onlyThese highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE.PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2012prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-04-021525840142
47ded7d58-56c3-41e3-94b1-a6bba34a91f0 (view SPL)PHENYLEPHRINE HYDROCHLORIDE INJECTION, USP 1%prescriptionHuman PrescriptionCardinal HealthREPACK2012-07-032551545735
57dfaac8d-ceab-4af0-9c44-bed73414789d (view SPL)PhenylephrineHydrochloride Injection, USPRx only CONTAINS NO ANTIMICROBIAL PRESERVATIVEprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-181551545128
684134033-79e4-4660-a3bf-7adfd90fd01d (view SPL)PhenylephrineHydrochloride Injection, USPRx only CONTAINS NO ANTIMICROBIAL PRESERVATIVEprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2011-08-244006416088
7b6d3c9af-53f7-4c14-8608-f41a3ef9894d (view SPL)Phenylephrine HCL 1 mL fill in 2 mL 10 mg/mL Injection, USP Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2011-04-263525840016
8bc7981a2-b950-4e27-9aef-a3f6d2d39039 (view SPL)Phenylephrine Hydrochloride Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-04-044551542852
9e1a7ab4b-0afe-4463-a039-5be0323cf2f7 (view SPL)These highlights do not include all the information needed to usePHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE. PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous useInitial U.S. Approval: 2012prescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE2014-06-036006416142

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII