NDC 27808-065

Promethazine Hydrochloride and Codeine Phosphate

Promethazine Hydrochloride And Codeine Phosphate

Promethazine Hydrochloride and Codeine Phosphate is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc. The primary component is Promethazine Hydrochloride; Codeine Phosphate.

Product ID27808-065_e8f8e43f-5237-472f-b991-f08d6d30fac8
NDC27808-065
Product TypeHuman Prescription Drug
Proprietary NamePromethazine Hydrochloride and Codeine Phosphate
Generic NamePromethazine Hydrochloride And Codeine Phosphate
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-03-12
Marketing CategoryANDA / ANDA
Application NumberANDA200386
Labeler NameTris Pharma Inc
Substance NamePROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
Active Ingredient Strength6 mg/5mL; mg/5mL
Pharm ClassesPhenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCV
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 27808-065-02

473 mL in 1 BOTTLE, PLASTIC (27808-065-02)
Marketing Start Date2018-03-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27808-065-02 [27808006502]

Promethazine Hydrochloride and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA200386
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-03-12

NDC 27808-065-01 [27808006501]

Promethazine Hydrochloride and Codeine Phosphate SOLUTION
Marketing CategoryANDA
Application NumberANDA200386
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-12
Marketing End Date2019-03-08

Drug Details

Active Ingredients

IngredientStrength
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

OpenFDA Data

SPL SET ID:785c605e-1907-4fac-8b69-d504a2076f8e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991486
    • UPC Code
  • 0327808065025

    • Pharmacological Class

    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]
    • Phenothiazine [EPC]
    • Phenothiazines [CS]
    • Full Opioid Agonists [MoA]
    • Opioid Agonist [EPC]

    Medicade Reported Pricing

    27808006502 PROMETHAZINE-CODEINE SYRUP

    Pricing Unit: ML | Drug Type:

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

    NDCBrand NameGeneric Name
    0121-0547PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
    12634-907promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    12634-909Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0065Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    17856-0804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    27808-065Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    50383-804Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    63187-595promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    70408-185promethazine hydrochloride and codeine phosphatepromethazine hydrochloride and codeine phosphate
    70752-139Promethazine Hydrochloride and Codeine PhosphatePromethazine Hydrochloride and Codeine Phosphate
    42254-140Prometh with CodeinePromethazine Hydrochloride and Codeine Phosphate
    0121-0928Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    0603-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    17856-0605Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    17856-1585Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    21695-336Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    33261-391Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    49999-152Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    50090-4127Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    50436-1029Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    52959-118PROMETHAZINE WITH CODEINEPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
    53002-3270Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    60432-606Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    63187-271Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    67296-0516Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
    68071-1606Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    68071-4037Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    68788-9895Promethazine with CodeinePromethazine Hydrochloride and Codeine Phosphate
    70166-555Promethazine with Codeinepromethazine hydrochloride and codeine phosphate
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