FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral

Product NDC
50090-6585
11-digit product format
500906585
Labeler code
50090
Product ID
50090-6585_146ea904-9204-4638-bcd3-b42aebee0845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040649
Marketing category
ANDA
Marketing start
2020-10-05
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
15; 6.25 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R61ZEH7I1I
Rxcui991528

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6585-0Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral118 mL in 1 BOTTLESOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6585-0ML - Milliliter50090-658541db1630-be8f-4b6b-b538-b7dfe8884e7312023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6585PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION [A-S MEDICATION SOLUTIONS]2Current NDC, 1 package rows20230814_9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25.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 SolutionPSN9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6585-050090658500118 mL in 1 BOTTLE (50090-6585-0) 118 ml2023-08-09NoNoHistorical