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NDC 53746-0146-01 Hydrocodone Bitartrate and Ibuprofen 5; 200 mg/1; mg/1 Details
Hydrocodone Bitartrate and Ibuprofen 5; 200 mg/1; mg/1
Hydrocodone Bitartrate and Ibuprofen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals of New York LLC. The primary component is HYDROCODONE BITARTRATE; IBUPROFEN.
MedlinePlus Drug Summary
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: 53746-0146-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocodone Combination Products
Product Information
| NDC | 53746-0146 |
|---|---|
| Product ID | 53746-146_6605b229-ede5-4ebf-b749-dde315916268 |
| Associated GPIs | 65991702500315 |
| GCN Sequence Number | 054674 |
| GCN Sequence Number Description | hydrocodone/ibuprofen TABLET 5MG-200MG ORAL |
| HIC3 | H3N |
| HIC3 Description | OPIOID ANALGESIC AND NSAID COMBINATION |
| GCN | 22678 |
| HICL Sequence Number | 014296 |
| HICL Sequence Number Description | HYDROCODONE/IBUPROFEN |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocodone Bitartrate and Ibuprofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocodone Bitartrate and Ibuprofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5; 200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | HYDROCODONE BITARTRATE; IBUPROFEN |
| Labeler Name | Amneal Pharmaceuticals of New York LLC |
| Pharmaceutical Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA076642 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53746-0146-01 (53746014601)
| NDC Package Code | 53746-146-01 |
|---|---|
| Billing NDC | 53746014601 |
| Package | 100 TABLET in 1 BOTTLE (53746-146-01) |
| Marketing Start Date | 2010-02-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |