dextromethorphan polistirex extended release
- Product NDC
- 45802-433
- 11-digit product format
- 458020433
- Labeler code
- 45802
- Product ID
- 45802-433_089bd748-c172-48a7-932a-f96ad7b0515a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- dextromethorphan polistirex
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- 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 |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9D2RTI9KYH |
| Rxcui | 1373045 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| a90f088a-9578-47a2-8f6e-0a9d32aafec6 | Product name | 1 | 20181030 |
| f6c90bdc-1674-455a-aadd-1b1b59e5edeb | Product name | 2 | 20181030 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| f1ec5c2f-d01e-a277-5826-c7eba86ed99b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-433-21 | dextromethorphan polistirex extended release | 89 mL in 1 BOTTLE | SUSPENSION | 89 | 6 | |
| 45802-433-21 | dextromethorphan polistirex extended release | 1 in 1 CARTON | SUSPENSION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-433-21 | ML - Milliliter | 45802-433 | af1113d3-4f00-4a61-8cf1-e110bd462d5e | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 45802-433 | DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250213_7a6b68eb-8fe0-447d-aed7-28432c45b58c.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 7a6b68eb-8fe0-447d-aed7-28432c45b58c | 6 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 7a6b68eb-8fe0-447d-aed7-28432c45b58c | 6 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 7a6b68eb-8fe0-447d-aed7-28432c45b58c | 6 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 7a6b68eb-8fe0-447d-aed7-28432c45b58c | 6 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | 8007a226-f0d2-4618-af13-33c807f36ab5 | 2 |
| 1373045 | dextromethorphan polistirex 30 MG in 5 mL 12HR Extended Release Oral Suspension | PSN | bd415342-90e1-411b-b6c9-652e9532c611 | 2 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | 8007a226-f0d2-4618-af13-33c807f36ab5 | 2 |
| 1373045 | 12 HR dextromethorphan polistirex 6 MG/ML Extended Release Suspension | SCD | bd415342-90e1-411b-b6c9-652e9532c611 | 2 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | 8007a226-f0d2-4618-af13-33c807f36ab5 | 2 |
| 1373045 | dextromethorphan polistirex (dextromethorphan HBr 30 MG) per 5 ML 12 HR Extended Release Suspension | SY | bd415342-90e1-411b-b6c9-652e9532c611 | 2 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | 8007a226-f0d2-4618-af13-33c807f36ab5 | 2 |
| 1373045 | dextromethorphan polistirex 6 MG/ML 12 HR Extended Release Suspension | SY | bd415342-90e1-411b-b6c9-652e9532c611 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-433-21 | 45802043321 | 1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE | 1 bottle | 2012-09-10 | 0000-00-00 | No | No | Current |