FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
50090-6755
11-digit product format
500906755
Labeler code
50090
Product ID
50090-6755_488420f1-eee8-408d-86eb-45209304a36c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091687
Marketing category
ANDA
Marketing start
2014-01-31
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

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
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
50090-6755-0Promethazine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSOLUTION4735
50090-6755-1Promethazine Hydrochloride and Dextromethorphan Hydrobromide118 mL in 1 BOTTLESOLUTION1185
50090-6755-1Promethazine Hydrochloride and Dextromethorphan Hydrobromide4 in 1 BOTTLESOLUTION45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6755-1ML - Milliliter50090-67555b5646d1-35a7-4867-8b58-105ff934bf2612024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6755PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [A-S MEDICATION SOLUTIONS]5Current NDC, 3 package rows20240214_e451cb8d-f856-479f-bee9-4cccab210b1e.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 SolutionPSNe451cb8d-f856-479f-bee9-4cccab210b1e5
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDe451cb8d-f856-479f-bee9-4cccab210b1e5
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYe451cb8d-f856-479f-bee9-4cccab210b1e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6755-050090675500473 mL in 1 BOTTLE, PLASTIC (50090-6755-0) 473 ml2023-10-17NoNoHistorical
50090-6755-1500906755014 BOTTLE in 1 BOTTLE (50090-6755-1) / 118 mL in 1 BOTTLE4 bottle2024-02-05NoNoHistorical