FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX

Product NDC
58602-610
11-digit product format
586020610
Labeler code
58602
Product ID
58602-610_126b5a4d-b915-4fe8-9156-a94d729ac47d
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
2026-04-15
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-610-05DEXTROMETHORPHAN POLISTIREX89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE892
58602-610-05DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
58602-610-06DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
58602-610-06DEXTROMETHORPHAN 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 SuspensionPSN4fde00af-3824-44f1-8a5f-d88518e0a8c82
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD4fde00af-3824-44f1-8a5f-d88518e0a8c82
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY4fde00af-3824-44f1-8a5f-d88518e0a8c82
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY4fde00af-3824-44f1-8a5f-d88518e0a8c82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-610-05586020610051 BOTTLE in 1 CARTON (58602-610-05) / 89 mL in 1 BOTTLE1 bottle2026-04-15NoNoHistorical
58602-610-06586020610061 BOTTLE in 1 CARTON (58602-610-06) / 148 mL in 1 BOTTLE1 bottle2026-04-15NoNoHistorical