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NDC 47781-0398-60 Hydrocodone Bitartrate 120 mg/1 Details
Hydrocodone Bitartrate 120 mg/1
Hydrocodone Bitartrate is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alvogen Inc.. The primary component is HYDROCODONE BITARTRATE.
MedlinePlus Drug Summary
Hydrocodone is used to relieve severe pain. Hydrocodone is only used to treat people who are expected to need medication to relieve severe pain around-the-clock for a long time and who cannot be treated with other medications or treatments. Hydrocodone extended-release (long-acting) capsules or extended-release tablets should not be used to treat pain that can be controlled by medication that is taken as needed. Hydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. This monograph only includes information about the use of hydrocodone alone. If you are taking a hydrocodone combination product, be sure to read information about all the ingredients in the hydrocodone-combination monograph and ask your doctor or pharmacist for more information.
Related Packages: 47781-0398-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocodone
Product Information
| NDC | 47781-0398 |
|---|---|
| Product ID | 47781-398_ca1e12ee-5cca-c1d2-509f-ed171902d723 |
| Associated GPIs | 6510003010A870 |
| GCN Sequence Number | 073183 |
| GCN Sequence Number Description | hydrocodone bitartrate TAB ER 24H 120 MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 37547 |
| HICL Sequence Number | 001731 |
| HICL Sequence Number Description | HYDROCODONE BITARTRATE |
| Brand/Generic | Generic |
| Proprietary Name | Hydrocodone Bitartrate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Hydrocodone Bitartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 120 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROCODONE BITARTRATE |
| Labeler Name | Alvogen Inc. |
| Pharmaceutical Class | Opioid Agonist [EPC], Opioid Agonists [MoA] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA208269 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 47781-0398-60 (47781039860)
| NDC Package Code | 47781-398-60 |
|---|---|
| Billing NDC | 47781039860 |
| Package | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-398-60) |
| Marketing Start Date | 2021-03-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |