Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Product NDC
17856-0604
11-digit product format
178560604
Labeler code
17856
Product ID
17856-0604_bdc594a6-ff16-4cf7-bcc8-119738fd7edd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA088864
Marketing category
ANDA
Marketing start
1985-01-04
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
15 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0604-4Dextromethorphan Hydrobromide and Promethazine Hydrochloride72 in 1 BOXSYRUP725
17856-0604-5Dextromethorphan Hydrobromide and Promethazine Hydrochloride5 mL in 1 CUPSYRUP55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0604-5ML - Milliliter17856-060455972272-742e-4cad-b5c3-7d534e60724812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
DextromethorphanACTIVE MOIETY7355X3ROTSDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
PromethazineACTIVE MOIETYFF28EJQ494DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
PINEAPPLEINACTIVE INGREDIENT2A88ZO081ODEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RDEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0604DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORP.]5Legacy NDC, 2 package rows20240606_ba7ad7f8-3261-4977-a13a-f6e07c510a9a.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 SolutionPSNba7ad7f8-3261-4977-a13a-f6e07c510a9a5
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDba7ad7f8-3261-4977-a13a-f6e07c510a9a5
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYba7ad7f8-3261-4977-a13a-f6e07c510a9a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0604-41785606040472 CUP in 1 BOX (17856-0604-4) > 5 mL in 1 CUP (17856-0604-5) 72 cup2022-06-080000-00-00NoNoCurrent
17856-0604-5178560604055 mL in 1 CUP5 mlHistorical