FDA.reportPublic FDA data

Dextromethorphan Polistirex Extended-Release

Product NDC
65162-799
11-digit product format
651620799
Labeler code
65162
Product ID
65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Polistirex
Dosage form
SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203133
Marketing category
ANDA
Marketing start
2017-08-01
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a90f088a-9578-47a2-8f6e-0a9d32aafec6Product name120181030
f6c90bdc-1674-455a-aadd-1b1b59e5edebProduct name220181030
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-799-76Dextromethorphan Polistirex Extended-Release89 mL in 1 BOTTLESUSPENSION8910
65162-799-76Dextromethorphan Polistirex Extended-Release1 in 1 CARTONSUSPENSION110
65162-799-77Dextromethorphan Polistirex Extended-Release1 in 1 CARTONSUSPENSION110
65162-799-77Dextromethorphan Polistirex Extended-Release148 mL in 1 BOTTLESUSPENSION14810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-799DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 4 package rows20240707_e0104a59-0bc2-4401-8c14-7f28499dbac6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373045dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral SuspensionPSNe0104a59-0bc2-4401-8c14-7f28499dbac610
137304512 HR dextromethorphan polistirex 6 MG/ML Extended Release SuspensionSCDe0104a59-0bc2-4401-8c14-7f28499dbac610
1373045dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release SuspensionSYe0104a59-0bc2-4401-8c14-7f28499dbac610
1373045dextromethorphan polistirex 6 MG/ML 12 HR Extended Release SuspensionSYe0104a59-0bc2-4401-8c14-7f28499dbac610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-799-76651620799761 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLE1 bottle2017-08-010000-00-00NoNoCurrent
65162-799-77651620799771 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLE1 bottle2017-08-010000-00-00NoNoCurrent