NDC 0603-1587

Promethazine VC

Promethazine Hydrochloride And Phenylephrine Hydrochloride

Promethazine VC is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical. The primary component is Promethazine Hydrochloride; Phenylephrine Hydrochloride.

Product ID0603-1587_d354d495-9cf3-4e2e-a7b2-3a6ef22e260a
NDC0603-1587
Product TypeHuman Prescription Drug
Proprietary NamePromethazine VC
Generic NamePromethazine Hydrochloride And Phenylephrine Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2006-12-07
Marketing CategoryANDA / ANDA
Application NumberANDA040654
Labeler NamePar Pharmaceutical
Substance NamePROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength6 mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0603-1587-58

473 mL in 1 BOTTLE (0603-1587-58)
Marketing Start Date2006-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0603-1587-56 [00603158756]

Promethazine VC SOLUTION
Marketing CategoryANDA
Application NumberANDA040654
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-07
Marketing End Date2017-04-14

NDC 0603-1587-58 [00603158758]

Promethazine VC SOLUTION
Marketing CategoryANDA
Application NumberANDA040654
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-12-07
Marketing End Date2019-10-31

NDC 0603-1587-54 [00603158754]

Promethazine VC SOLUTION
Marketing CategoryANDA
Application NumberANDA040654
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-12-07
Marketing End Date2013-05-31

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:cf73c2e3-f43b-403f-a461-47438a7270ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248057
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0121-0926Promethazine VCPromethazine Hydrochloride and Phenylephrine Hydrochloride
    0603-1587Promethazine VCPromethazine hydrochloride and phenylephrine hydrochloride
    68788-6763Promethazine VCPromethazinehydrochloride and phenylephrine hydrochloride
    68788-9100Promethazine VCPromethazinehydrochloride and phenylephrine hydrochloride
    50383-802Promethazine Hydrochloride and Phenylephrine HydrochloridePromethazine Hydrochloride and Phenylephrine Hydrochloride

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