FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX

Product NDC
58602-618
11-digit product format
586020618
Labeler code
58602
Product ID
58602-618_1fc535f0-ed20-41b7-bd83-9e6fc36d831d
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN POLISTIREX
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA218417
Marketing category
ANDA
Marketing start
2026-04-17
Substance
DEXTROMETHORPHAN
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DEXTROMETHORPHAN POLISTIREX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN30 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7355X3ROTS
Rxcui1373045

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-618-05DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
58602-618-05DEXTROMETHORPHAN POLISTIREX89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE892
58602-618-06DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
58602-618-06DEXTROMETHORPHAN POLISTIREX148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1482

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNfc328034-ad2a-4f7d-81cf-f4da4e64f5d72
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDfc328034-ad2a-4f7d-81cf-f4da4e64f5d72
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYfc328034-ad2a-4f7d-81cf-f4da4e64f5d72
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYfc328034-ad2a-4f7d-81cf-f4da4e64f5d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-618-05586020618051 BOTTLE in 1 CARTON (58602-618-05) / 89 mL in 1 BOTTLE1 bottle2026-04-17NoNoCurrent
58602-618-06586020618061 BOTTLE in 1 CARTON (58602-618-06) / 148 mL in 1 BOTTLE1 bottle2026-04-17NoNoCurrent