FDA.reportPublic FDA data

Dextromethorphan Hydrobromide and Promethazine Hydrochloride

Product NDC
63187-355
11-digit product format
631870355
Labeler code
63187
Product ID
63187-355_237dfeed-9ff8-4ae1-81fd-1322cf252599
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dextromethorphan Hydrobromide and Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Proficient Rx LP
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63187-355-042025-06-25C16284748780-1ba0f9c33-252d-a910-e053-dadaa90a0b85c155b478-c04d-47e5-891b-408d09a5acf3
63187-355-162025-06-25C16284748780-1ba0f9c33-252d-a910-e053-dadaa90a0b85c155b478-c04d-47e5-891b-408d09a5acf3
63187-355-042021-01-29C16284748780-1ba0f9c33-252d-a910-e053-dadaa90a0b85c155b478-c04d-47e5-891b-408d09a5acf3
63187-355-162021-01-29C16284748780-1ba0f9c33-252d-a910-e053-dadaa90a0b85c155b478-c04d-47e5-891b-408d09a5acf3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-355-16ML - Milliliter63187-355de6b153d-c74f-4375-8224-8b80a2b677cf12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-355DEXTROMETHORPHAN HYDROBROMIDE AND PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]3Legacy NDC20190130_c155b478-c04d-47e5-891b-408d09a5acf3.zip