NDC 52584-577

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride

Phenylephrine Hydrochloride is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Phenylephrine Hydrochloride.

Product ID52584-577_1658e8d9-9ff7-48af-ab81-a0c1907449a5
NDC52584-577
Product TypeHuman Prescription Drug
Proprietary NamePhenylephrine Hydrochloride
Generic NamePhenylephrine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-07-23
Marketing End Date2023-04-30
Marketing CategoryANDA / ANDA
Application NumberANDA211079
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAdrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN

Packaging

NDC 52584-577-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-577-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-07-23
Marketing End Date2023-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-577-01 [52584057701]

Phenylephrine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA211079
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-23

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:5f44cfe7-3d3f-40a8-9917-ac1c3060025c
Manufacturer
UNII

Pharmacological Class

  • 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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