PROMETHAZINE DM

Product NDC
33261-732
11-digit product format
332610732
Labeler code
33261
Product ID
33261-732_2c926159-2df1-424e-b19f-197833e3dd10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-732-012020-01-31C16284748780-19d75b9d0-767e-f424-e053-dadaa90a57cePROMETHAZINE DM SYRUP (PROMETHAZINE HYDROCHLORIDE, USP AND DEXTROMETHORPHAN HYDROBROMIDE, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-732-01PROMETHAZINE DM118 mL in 1 BOTTLE, PLASTICSYRUP1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-732-01ML - Milliliter33261-732f9e6b8cf-a90b-4cb2-bfe0-125c8e5c0a4c12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-732PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SYRUP [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140207_5024bf2c-d0f8-4838-8d93-d435bad05803.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN5024bf2c-d0f8-4838-8d93-d435bad058031
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD5024bf2c-d0f8-4838-8d93-d435bad058031
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY5024bf2c-d0f8-4838-8d93-d435bad058031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-732-0133261073201118 mL in 1 BOTTLE, PLASTIC118 mlHistorical