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NDC 00574-0294-01 hydromorphone hydrochloride 12 mg/1 Details
hydromorphone hydrochloride 12 mg/1
hydromorphone hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Padagis US LLC. The primary component is HYDROMORPHONE HYDROCHLORIDE.
MedlinePlus Drug Summary
Hydromorphone is used to relieve pain. Hydromorphone extended-release tablets are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Hydromorphone extended-release tablets should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week and should not be used to treat mild or moderate pain, short-term pain, pain after an operation or medical or dental procedure, or pain that can be controlled by medication that is taken as needed. Hydromorphone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Related Packages: 00574-0294-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydromorphone
Product Information
| NDC | 00574-0294 |
|---|---|
| Product ID | 0574-0294_185636e1-ed9d-4a36-bac9-1ea7026d2b42 |
| Associated GPIs | 65100035107531 |
| GCN Sequence Number | 066200 |
| GCN Sequence Number Description | hydromorphone HCl TAB ER 24H 12 MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 28427 |
| HICL Sequence Number | 001695 |
| HICL Sequence Number Description | HYDROMORPHONE HCL |
| Brand/Generic | Generic |
| Proprietary Name | hydromorphone hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydromorphone hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 12 |
| Active Ingredient Units | mg/1 |
| Substance Name | HYDROMORPHONE HYDROCHLORIDE |
| Labeler Name | Padagis US LLC |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |
| Marketing Category | ANDA |
| Application Number | ANDA204278 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00574-0294-01 (00574029401)
| NDC Package Code | 0574-0294-01 |
|---|---|
| Billing NDC | 00574029401 |
| Package | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0574-0294-01) |
| Marketing Start Date | 2015-05-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |