NDC 55045-1266

Promethazine VC With Codeine

Codeine Phosphate, Promethazine Hydrochloride, And Phenylephrine Hydrochloride

Promethazine VC With Codeine is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Dispensing Solutions, Inc.. The primary component is Codeine Phosphate; Promethazine Hydrochloride; Phenylephrine Hydrochloride.

Product ID55045-1266_e3562eaf-3ea6-4b11-903d-43479c7a1f1a
NDC55045-1266
Product TypeHuman Prescription Drug
Proprietary NamePromethazine VC With Codeine
Generic NameCodeine Phosphate, Promethazine Hydrochloride, And Phenylephrine Hydrochloride
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2006-12-07
Marketing CategoryANDA / ANDA
Application NumberANDA040660
Labeler NameDispensing Solutions, Inc.
Substance NameCODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength10 mg/5mL; mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
DEA ScheduleCV
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55045-1266-8

118 mL in 1 BOTTLE (55045-1266-8)
Marketing Start Date2006-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55045-1266-8 [55045126608]

Promethazine VC With Codeine SYRUP
Marketing CategoryANDA
Application NumberANDA040660
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-12-07
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
CODEINE PHOSPHATE10 mg/5mL

OpenFDA Data

SPL SET ID:5c3c2c1b-ab52-410b-8c94-c125c6adb4d2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 996757
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Promethazine VC With Codeine" or generic name "Codeine Phosphate, Promethazine Hydrochloride, And Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    0603-1588Promethazine VC with CodeinePromethazine and Phenylephrine Hydrochloride and Codeine Phosphate
    55045-1266Promethazine VC With CodeineCodeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride

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