Prescription drug · ANDA
Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDC 65162-680
Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL · Solution · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-680-86 | 6516206808665162068086 | 118 mL in 1 BOTTLE (65162-680-86)Marketed from Mar 4, 2011 | |
| 65162-680-90 | 6516206809065162068090 | 473 mL in 1 BOTTLE (65162-680-90)Marketed from Mar 4, 2011 |
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)
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Generic name (nonproprietary)
- promethazine hydrochloride and dextromethorphan hydrobromide
- Active ingredients
- Promethazine hydrochloride — 6.25 mg/5mLDextromethorphan hydrobromide — 15 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090575
- Marketing start
- Listing expires
- Other FDA classes
- Phenothiazines (Chemical structure)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 65162-680_5897cff8-507a-42b0-bcf2-4712589704dfSPL ID 5897cff8-507a-42b0-bcf2-4712589704dfSPL set ID 6081c216-0bed-40f0-8732-f999647003d5RxCUI 991528UNII R61ZEH7I1I, 9D2RTI9KYH
- Pharmacologic class
- Phenothiazine; 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
N465162068086followed by a unit qualifier and the quantityPackage 65162-0680-86. 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 Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Excerpt only. Read the full label for complete information.
About NDC 65162-680
- What is NDC 65162-680?
- 65162-680 is the product NDC for Promethazine Hydrochloride and Dextromethorphan Hydrobromide, Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL solution, 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?
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide.
- What is the active ingredient?
- Promethazine hydrochloride, 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 Promethazine Hydrochloride and Dextromethorphan Hydrobromide?
- 16 other product NDCs are listed under this name. See all Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Promethazine Hydrochloride and Dextromethorphan Hydrobromide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Advagen Pharma Ltd | 72888-038 | 72888-0038-0172888-0038-02 |
| Promethazine Hydrochloride And Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-692 | 31722-0692-1131722-0692-47 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Cosette Pharmaceuticals, Inc. | 0713-0780 | 00713-0780-75 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | Xttrium Laboratories, Inc | 0116-4024 | 00116-4024-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | Atlantic Biologicals Corp. | 17856-4024 | 17856-4024-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SyrupOral | A-S Medication Solutions | 50090-7658 | 50090-7658-0050090-7658-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | Asclemed USA, Inc. | 76420-335 | 76420-0335-0476420-0335-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | Promethazine hydrochloride 6.25 mg/5mL; Dextromethorphan hydrobromide 15 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 62559-758 | 62559-0758-0462559-0758-16 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0155 | 17856-0155-01 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | Dextromethorphan hydrobromide 15 mg/5mL; Promethazine hydrochloride 6.25 mg/5mL | SolutionOral | A-S Medication Solutions | 50090-6585 | 50090-6585-00 |
All 17 Promethazine Hydrochloride and Dextromethorphan Hydrobromide NDCs