NDC 63323-751

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Phenylephrine Hydrochloride.

Product ID63323-751_1c6b86a6-685d-4a27-ac00-6cdb032bd440
NDC63323-751
Product TypeHuman Prescription Drug
Proprietary NamePhenylephrine Hydrochloride
Generic NamePhenylephrine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA210665
Labeler NameFresenius Kabi USA, LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm Classesalpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63323-751-13

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-751-13) > 1 mL in 1 VIAL, SINGLE-DOSE (63323-751-03)
Marketing Start Date2019-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-751-03 [63323075103]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210665
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-25

NDC 63323-751-10 [63323075110]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210666
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-25

NDC 63323-751-00 [63323075100]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-25

NDC 63323-751-05 [63323075105]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210666
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-25

NDC 63323-751-01 [63323075101]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210665
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-25

NDC 63323-751-13 [63323075113]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA210665
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-25

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:1e77b9c8-fa17-4aa4-adc8-ff716ab2e5d7
Manufacturer
UNII

Pharmacological Class

  • alpha-1 Adrenergic Agonist [EPC]
  • Adrenergic alpha1-Agonists [MoA]
  • alpha-1 Adrenergic Agonist [EPC]
  • Adrenergic alpha1-Agonists [MoA]

NDC Crossover Matching brand name "Phenylephrine Hydrochloride" or generic name "Phenylephrine Hydrochloride"

NDCBrand NameGeneric Name
0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
69097-534PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE
69097-535Phenylephrine hydrochloridePhenylephrine hydrochloride
69097-614Phenylephrine hydrochloridePhenylephrine hydrochloride
70121-1579Phenylephrine hydrochloridePhenylephrine hydrochloride
70121-1578Phenylephrine hydrochloridePhenylephrine hydrochloride
70121-1577Phenylephrine hydrochloridePhenylephrine hydrochloride
70518-1038Phenylephrine HydrochloridePhenylephrine Hydrochloride
11673-394phenylephrine hydrochloridephenylephrine hydrochloride
17478-201Phenylephrine HydrochloridePhenylephrine Hydrochloride
17478-206Phenylephrine HydrochloridePhenylephrine Hydrochloride
42023-213Phenylephrine hydrochloridePhenylephrine hydrochloride
42023-214Phenylephrine hydrochloridePhenylephrine hydrochloride
42023-215Phenylephrine hydrochloridePhenylephrine hydrochloride
42702-102Phenylephrine HydrochloridePhenylephrine Hydrochloride
42702-103Phenylephrine HydrochloridePhenylephrine Hydrochloride
50730-4812phenylephrine hydrochloridephenylephrine hydrochloride
52584-142PHENYLEPHRINE HYDROCHLORIDEPHENYLEPHRINE HYDROCHLORIDE
55154-5129Phenylephrine HydrochloridePhenylephrine Hydrochloride
57344-131Phenylephrine HydrochloridePhenylephrine Hydrochloride
71872-7159Phenylephrine hydrochloridePhenylephrine hydrochloride
63323-751Phenylephrine HydrochloridePhenylephrine Hydrochloride
52584-577Phenylephrine HydrochloridePhenylephrine Hydrochloride
55154-8226Phenylephrine hydrochloridePhenylephrine hydrochloride
50090-4514Phenylephrine HydrochloridePhenylephrine Hydrochloride
50090-4515Phenylephrine HydrochloridePhenylephrine Hydrochloride
0781-3466Phenylephrine HydrochloridePhenylephrine Hydrochloride
0067-20864 WayPhenylephrine hydrochloride
0113-7094basic care sinus pePhenylephrine Hydrochloride
0363-0390ephrine nosePhenylephrine hydrochloride
0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
0363-0717nasalPhenylephrine hydrochloride
0295-1117Neo-SynephrinePhenylephrine hydrochloride
0295-1118Neo-SynephrinePhenylephrine hydrochloride
0295-1119Neo-SynephrinePhenylephrine hydrochloride
0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
0113-2004sinus PEPhenylephrine Hydrochloride
0363-0648Wal FourPhenylephrine hydrochloride
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