PROMETHAZINE DM

Product NDC
50090-4125
11-digit product format
500904125
Labeler code
50090
Product ID
50090-4125_4b62ac0f-8c71-4dd1-a148-7119bc6d1629
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
A-S Medication Solutions
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
2020-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4125-02023-01-30C16284748780-1f386c64a-1fff-0266-e053-dadaa90a7c1aPromethazine DM Oral Solution (Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4125-0PROMETHAZINE DM473 mL in 1 BOTTLESOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4125PROMETHAZINE DM (DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE) SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 1 package rows20190212_b84e85a1-70f3-4223-b77a-5b46b328303f.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 SolutionPSNb84e85a1-70f3-4223-b77a-5b46b328303f2
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDb84e85a1-70f3-4223-b77a-5b46b328303f2
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYb84e85a1-70f3-4223-b77a-5b46b328303f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4125-050090412500473 mL in 1 BOTTLE (50090-4125-0) 473 ml2019-02-040000-00-00NoNoCurrent