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NDC 43386-0351-03 Hydrocodone Bitartrate and Acetaminophen 300; 5 mg/1; mg/1 Details
Hydrocodone Bitartrate and Acetaminophen 300; 5 mg/1; mg/1
Hydrocodone Bitartrate and Acetaminophen is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals,Inc.. The primary component is ACETAMINOPHEN; HYDROCODONE BITARTRATE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 43386-0351-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 43386-0351-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocodone Combination Products
Product Information
| NDC | 43386-0351 |
|---|---|
| Product ID | 43386-351_322b2034-bf51-4765-a52b-43e3a4062135 |
| Associated GPIs | 65991702100309 |
| GCN Sequence Number | 060338 |
| GCN Sequence Number Description | hydrocodone/acetaminophen TABLET 5 MG-300MG ORAL |
| HIC3 | H3U |
| HIC3 Description | OPIOID ANALGESIC AND NON-SALICYLATE ANALGESICS |
| GCN | 26470 |
| HICL Sequence Number | 001730 |
| HICL Sequence Number Description | HYDROCODONE BITARTRATE/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 300; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Labeler Name | Lupin Pharmaceuticals,Inc. |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA206142 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43386-0351-03 (43386035103)
| NDC Package Code | 43386-351-03 |
|---|---|
| Billing NDC | 43386035103 |
| Package | 30 TABLET in 1 BOTTLE (43386-351-03) |
| Marketing Start Date | 2016-11-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |