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NDC 50383-0804-16 Promethazine Hydrochloride and Codeine Phosphate 10; 6.25 mg/5mL; mg/5mL Details
Promethazine Hydrochloride and Codeine Phosphate 10; 6.25 mg/5mL; mg/5mL
Promethazine Hydrochloride and Codeine Phosphate is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Akorn. The primary component is CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Codeine is used to relieve mild to moderate pain. It is also used, usually in combination with other medications, to reduce coughing. Codeine will help relieve symptoms but will not treat the cause of symptoms or speed recovery. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing. Codeine is also available in combination with acetaminophen (Capital and Codeine, Tylenol with Codeine), aspirin, carisoprodol, and promethazine and as an ingredient in many cough and cold medications. This monograph only includes information about the use of codeine. If you are taking a codeine combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
Related Packages: 50383-0804-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Codeine
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: 50383-0804-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Promethazine
Product Information
| NDC | 50383-0804 |
|---|---|
| Product ID | 50383-804_6994efab-2353-4868-bcde-c3ee3a2b1e8e |
| Associated GPIs | 43995202341210 |
| GCN Sequence Number | 048489 |
| GCN Sequence Number Description | promethazine HCl/codeine SYRUP 6.25-10/5 ORAL |
| HIC3 | B4D |
| HIC3 Description | OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE |
| GCN | 13971 |
| HICL Sequence Number | 000345 |
| HICL Sequence Number Description | PROMETHAZINE HCL/CODEINE |
| Brand/Generic | Generic |
| Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Promethazine Hydrochloride and Codeine Phosphate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 6.25 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
| Labeler Name | Akorn |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS] |
| DEA Schedule | CV |
| Marketing Category | ANDA |
| Application Number | ANDA040151 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50383-0804-16 (50383080416)
| NDC Package Code | 50383-804-16 |
|---|---|
| Billing NDC | 50383080416 |
| Package | 473 mL in 1 BOTTLE (50383-804-16) |
| Marketing Start Date | 1997-08-26 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04276 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | PROMETHAZINE-CODEINE SYRUP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |