FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
21695-698
11-digit product format
216950698
Labeler code
21695
Product ID
21695-698_56dfd62c-d386-4e9f-9946-07eda94fa122
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Rebel Distributors 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
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
E
Listing certified through
2017-12-31
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
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
21695-698-042019-09-24C16284748780-1934fe258-4926-48b1-e053-8cdaa90a720aPROMETHAZINE WITH DEXTROMETHORPHAN COUGH SYRUP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-698-04Promethazine Hydrochloride and Dextromethorphan Hydrobromide118 mL in 1 BOTTLESYRUP1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-698-04ML - Milliliter21695-698ce028473-a4da-4329-a34a-4a4f872385a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
Promethazine hydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
DextromethorphanACTIVE MOIETY7355X3ROTSPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-698PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_56dfd62c-d386-4e9f-9946-07eda94fa122.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 SolutionPSN56dfd62c-d386-4e9f-9946-07eda94fa1221
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD56dfd62c-d386-4e9f-9946-07eda94fa1221
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY56dfd62c-d386-4e9f-9946-07eda94fa1221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-698-0421695069804118 mL in 1 BOTTLE118 mlHistorical