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NDC 65162-0680-86 Promethazine Hydrochloride and Dextromethorphan Hydrobromide 15; 6.25 mg/5mL; mg/5mL Details
Promethazine Hydrochloride and Dextromethorphan Hydrobromide 15; 6.25 mg/5mL; mg/5mL
Promethazine Hydrochloride and Dextromethorphan Hydrobromide is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 65162-0680-86Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Promethazine is used to relieve the symptoms of allergic reactions such as allergic rhinitis (runny nose and watery eyes caused by allergy to pollen, mold or dust), allergic conjunctivitis (red, watery eyes caused by allergies), allergic skin reactions, and allergic reactions to blood or plasma products. Promethazine is used with other medications to treat anaphylaxis (sudden, severe allergic reactions) and the symptoms of the common cold such as sneezing, cough, and runny nose. Promethazine is also used to relax and sedate patients before and after surgery, during labor, and at other times. Promethazine is also used to prevent and control nausea and vomiting that may occur after surgery, and with other medications to help relieve pain after surgery. Promethazine is also used to prevent and treat motion sickness. Promethazine helps control symptoms, but will not treat the cause of the symptoms or speed recovery. Promethazine is in a class of medications called phenothiazines. It works by blocking the action of a certain natural substance in the body.
Related Packages: 65162-0680-86Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Promethazine
Product Information
| NDC | 65162-0680 |
|---|---|
| Product ID | 65162-680_3236c3e4-8625-4dc0-bdbd-ee6c91aab6aa |
| Associated GPIs | 43995702301210 |
| GCN Sequence Number | 048493 |
| GCN Sequence Number Description | promethazine/dextromethorphan SYRUP 6.25-15/5 ORAL |
| HIC3 | B4E |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB. |
| GCN | 13975 |
| HICL Sequence Number | 000366 |
| HICL Sequence Number Description | PROMETHAZINE HCL/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Promethazine Hydrochloride and Dextromethorphan Hydrobromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 15; 6.25 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090575 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0680-86 (65162068086)
| NDC Package Code | 65162-680-86 |
|---|---|
| Billing NDC | 65162068086 |
| Package | 118 mL in 1 BOTTLE (65162-680-86) |
| Marketing Start Date | 2011-03-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06338 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | PROMETHAZINE-DM 6.25-15 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |