DEXTROMETHORPHAN Hydrobromide

Product NDC
68210-4133
11-digit product format
682104133
Labeler code
68210
Product ID
68210-4133_ee8bb577-e0a9-0585-e053-2995a90a03bb
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-04-28
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
15 mg/1
Pharmacologic classes
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4133-1DEXTROMETHORPHAN Hydrobromide15 in 1 BOTTLECAPSULE, LIQUID FILLED156
68210-4133-1DEXTROMETHORPHAN Hydrobromide1 in 1 CARTONCAPSULE, LIQUID FILLED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4133DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20241215_e8959420-f597-439a-abd1-ca1c0413669a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1090487dextromethorphan HBr 15 MG Oral CapsulePSNe8959420-f597-439a-abd1-ca1c0413669a6
1090487dextromethorphan hydrobromide 15 MG Oral CapsuleSCDe8959420-f597-439a-abd1-ca1c0413669a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4133-1682104133011 BOTTLE in 1 CARTON (68210-4133-1) > 15 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2021-04-280000-00-00NoNoCurrent