Over-the-counter drug · ANDA
Dextromethorphan Polistirex Extended-Release (Dextromethorphan polistirex) NDC 65162-700
Dextromethorphan hydrobromide 30 mg/5mL · Suspension · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-700-76 | 65162070076 | 1 BOTTLE in 1 CARTON (65162-700-76) / 89 mL in 1 BOTTLEMarketed from Aug 1, 2017 | |
| 65162-700-77 | 65162070077 | 1 BOTTLE in 1 CARTON (65162-700-77) / 148 mL in 1 BOTTLEMarketed from Aug 1, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Dextromethorphan Polistirex Extended-Release
- Generic name (nonproprietary)
- dextromethorphan polistirex
- Active ingredients
- Dextromethorphan hydrobromide — 30 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203133
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-700_df1662fe-6e62-4093-a047-654e3b700ab3SPL ID df1662fe-6e62-4093-a047-654e3b700ab3SPL set ID ce7402d1-e48f-4bf1-90e9-cc57a52b35e5RxCUI 1373045UNII 9D2RTI9KYH
- Pharmacologic class
- Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N465162070076followed by a unit qualifier and the quantityPackage 65162-0700-76. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Uses Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 65162-700
- What is NDC 65162-700?
- 65162-700 is the product NDC for Dextromethorphan Polistirex Extended-Release, Dextromethorphan hydrobromide 30 mg/5mL suspension, listed with the FDA by Amneal Pharmaceuticals LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextromethorphan Polistirex Extended-Release (Dextromethorphan Polistirex).
- What is the active ingredient?
- Dextromethorphan hydrobromide.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextromethorphan Polistirex Extended-Release?
- 3 other product NDCs are listed under this name. See all Dextromethorphan Polistirex Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dextromethorphan Polistirex Extended-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextromethorphan Polistirex Extended-Releasedextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amneal Pharmaceuticals LLC | 65162-799 | 65162-0799-7665162-0799-77 |
| dextromethorphan polistirex extended releasedextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Padagis Israel Pharmaceuticals Ltd | 45802-433 | 45802-0433-21 |
| dextromethorphan polistirex extended releasedextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Bryant Ranch Prepack | 72162-2281 | 72162-2281-02 |
Other NDCs under ANDA 203133
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dextromethorphan Polistirex Extended-Releasedextromethorphan polistirex | Dextromethorphan hydrobromide 30 mg/5mL | SuspensionOral | Amneal Pharmaceuticals LLC | 65162-799 |