FDA.reportPublic FDA data

dextromethorphan polistirex extended release

Product NDC
72162-2281
11-digit product format
721622281
Labeler code
72162
Product ID
72162-2281_af097075-983d-40e4-bf56-88d05d7e15d7
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091135
Marketing category
ANDA
Marketing start
2012-09-10
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
30 mg/5mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
dextromethorphan polistirex extended release
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH
Rxcui1373045

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2281-2dextromethorphan polistirex extended release89 mL in 1 BOTTLESUSPENSION892
72162-2281-2dextromethorphan polistirex extended release1 in 1 CARTONSUSPENSION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2281-2ML - Milliliter72162-22819f27c24a-d28a-4076-acf9-53cadb71813f12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2281DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [BRYANT RANCH PREPACK]2Current NDC, 2 package rows20250406_bd415342-90e1-411b-b6c9-652e9532c611.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNbd415342-90e1-411b-b6c9-652e9532c6112
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDbd415342-90e1-411b-b6c9-652e9532c6112
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYbd415342-90e1-411b-b6c9-652e9532c6112
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYbd415342-90e1-411b-b6c9-652e9532c6112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2281-2721622281021 BOTTLE in 1 CARTON (72162-2281-2) / 89 mL in 1 BOTTLE1 bottle2024-04-30NoNoHistorical