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NDC 76420-0537-30 TRAMADOL HYDROCHLORIDE 200 mg/1 Details
TRAMADOL HYDROCHLORIDE 200 mg/1
TRAMADOL HYDROCHLORIDE is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Asclemed USA, Inc.. The primary component is TRAMADOL HYDROCHLORIDE.
MedlinePlus Drug Summary
Tramadol immediate-release tablets and oral solution are used as a short-term treatment to relieve severe pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be controlled by the use of alternative pain medications. Tramadol extended-release tablets and capsules are used to relieve severe and persistent pain in people who are expected to need an opioid pain medication to relieve pain around-the-clock for a long time and who cannot be treated with other pain medications. Tramadol extended-release tablets and capsules should not be used to treat mild or moderate pain, short-term pain, or pain that can be controlled by medication that is taken as needed. Tramadol 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: 76420-0537-30Last Updated: 05/26/2024
MedLinePlus Full Drug Details: Tramadol
Product Information
| NDC | 76420-0537 |
|---|---|
| Product ID | 76420-537_f4ca3781-8aec-9696-e053-2a95a90adf9f |
| Associated GPIs | |
| GCN Sequence Number | 043536 |
| GCN Sequence Number Description | tramadol HCl TAB ER 24H 200 MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 50417 |
| HICL Sequence Number | 008317 |
| HICL Sequence Number Description | TRAMADOL HCL |
| Brand/Generic | Generic |
| Proprietary Name | TRAMADOL HYDROCHLORIDE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | TRAMADOL HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/1 |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Labeler Name | Asclemed USA, Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA200503 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 76420-0537-30 (76420053730)
| NDC Package Code | 76420-537-30 |
|---|---|
| Billing NDC | 76420053730 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-537-30) |
| Marketing Start Date | 2023-02-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |