PROMETHAZINE DM

Product NDC
63187-272
11-digit product format
631870272
Labeler code
63187
Product ID
63187-272_0d8718f0-8fa5-413b-bf23-5ffc1b190f85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040649
Marketing category
ANDA
Marketing start
2006-02-14
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
15 mg/5mL; mg/5mL
Pharmacologic classes
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3APROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-272PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SOLUTION [PROFICIENT RX LP]2Legacy NDC20191212_17bae9bf-ab07-4366-b400-871360c8969b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-272-0463187027204118 mL in 1 BOTTLE (63187-272-04) 118 ml2015-06-010000-00-00NoNoCurrent