NDC 50383-802

Promethazine Hydrochloride and Phenylephrine Hydrochloride

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Promethazine Hydrochloride and Phenylephrine Hydrochloride is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Phenylephrine Hydrochloride; Promethazine Hydrochloride.

Product ID50383-802_33abeace-5a58-404c-a3bd-8a16fdc60730
NDC50383-802
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride and Phenylephrine Hydrochloride
Generic NamePromethazine Hydrochloride And Phenylephrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-06-16
Marketing CategoryANDA / ANDA
Application NumberANDA040675
Labeler NameAkorn
Substance NamePHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
Pharm ClassesAdrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50383-802-04

118 mL in 1 BOTTLE (50383-802-04)
Marketing Start Date2015-06-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-802-04 [50383080204]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA040675
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-16

NDC 50383-802-16 [50383080216]

Promethazine Hydrochloride and Phenylephrine Hydrochloride SYRUP
Marketing CategoryANDA
Application NumberANDA040675
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-06-16

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:7d0b1461-6773-4f27-9302-6a88b6f86640
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248057
  • Pharmacological Class

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

    Medicade Reported Pricing

    50383080216 PROMETHAZINE-PHENYLEPHRINE SYR

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Promethazine Hydrochloride and Phenylephrine Hydrochloride" or generic name "Promethazine Hydrochloride And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    50383-802Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine Hydrochloride and Phenylephrine Hydrochloride
    65162-679Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine and Phenylephrine
    0121-0926Promethazine VCPromethazine Hydrochloride and Phenylephrine Hydrochloride
    0603-1587Promethazine VCPromethazine hydrochloride and phenylephrine hydrochloride

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