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NDC 63629-2303-01 Hydrocodone Polistirex and Chlorpheniramine Polistirex 8; 10 mg/5mL; mg/5mL Details
Hydrocodone Polistirex and Chlorpheniramine Polistirex 8; 10 mg/5mL; mg/5mL
Hydrocodone Polistirex and Chlorpheniramine Polistirex is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63629-2303-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve moderate-to-severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.
Related Packages: 63629-2303-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocodone Combination Products
Product Information
| NDC | 63629-2303 |
|---|---|
| Product ID | 63629-2303_694c3f95-5146-4b22-b28a-d2d6596451e8 |
| Associated GPIs | 4399520236G110 |
| GCN Sequence Number | 048492 |
| GCN Sequence Number Description | hydrocodone/chlorphen p-stirex SUS ER 12H 10-8MG/5ML ORAL |
| HIC3 | B4D |
| HIC3 Description | OPIOID ANTITUSSIVE-1ST GENERATION ANTIHISTAMINE |
| GCN | 13974 |
| HICL Sequence Number | 000352 |
| HICL Sequence Number Description | HYDROCODONE POLISTIREX/CHLORPHENIRAMINE POLISTIREX |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocodone Polistirex and Chlorpheniramine Polistirex |
| Proprietary Name Suffix | extended-release |
| Non-Proprietary Name | Hydrocodone Polistirex and Chlorpheniramine Polistirex |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 8; 10 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA091632 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63629-2303-01 (63629230301)
| NDC Package Code | 63629-2303-1 |
|---|---|
| Billing NDC | 63629230301 |
| Package | 1 BOTTLE, UNIT-DOSE in 1 CARTON (63629-2303-1) / 115 mL in 1 BOTTLE, UNIT-DOSE |
| Marketing Start Date | 2015-03-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |