FDA.reportPublic FDA data

DEXTROMETHORPHAN POLISTIREX

Product NDC
58602-617
11-digit product format
586020617
Labeler code
58602
Product ID
58602-617_272bae8c-f800-4cec-bc9a-014123bb81a6
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-617-05DEXTROMETHORPHAN POLISTIREX89 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE892
58602-617-05DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12
58602-617-06DEXTROMETHORPHAN POLISTIREX148 mL in 1 BOTTLESUSPENSION, EXTENDED RELEASE1482
58602-617-06DEXTROMETHORPHAN POLISTIREX1 in 1 CARTONSUSPENSION, EXTENDED RELEASE12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSN0fb8cdfc-3fa0-4773-813a-04c82b003bdf2
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCD0fb8cdfc-3fa0-4773-813a-04c82b003bdf2
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSY0fb8cdfc-3fa0-4773-813a-04c82b003bdf2
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSY0fb8cdfc-3fa0-4773-813a-04c82b003bdf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58602-617-05586020617051 BOTTLE in 1 CARTON (58602-617-05) / 89 mL in 1 BOTTLE1 bottle2026-04-17NoNoCurrent
58602-617-06586020617061 BOTTLE in 1 CARTON (58602-617-06) / 148 mL in 1 BOTTLE1 bottle2026-04-17NoNoCurrent