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NDC 61919-0818-30 TRAMADOL HCL 100 mg/1 Details
TRAMADOL HCL 100 mg/1
TRAMADOL HCL is a ORAL TABLET, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by DIRECT RX. The primary component is TRAMADOL HYDROCHLORIDE.
MedlinePlus Drug Summary
Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets and capsules are only used by people who are expected to need medication to relieve pain around-the-clock. 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: 61919-0818-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol
Product Information
| NDC | 61919-0818 |
|---|---|
| Product ID | 61919-818_fc5e0914-3e36-0be4-e053-6394a90aee7d |
| Associated GPIs | 65100095107520 |
| GCN Sequence Number | 060274 |
| GCN Sequence Number Description | tramadol HCl TAB ER 24H 100 MG ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 26387 |
| HICL Sequence Number | 008317 |
| HICL Sequence Number Description | TRAMADOL HCL |
| Brand/Generic | Generic |
| Proprietary Name | TRAMADOL HCL |
| Proprietary Name Suffix | ER |
| Non-Proprietary Name | TRAMADOL HCL |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Labeler Name | DIRECT RX |
| 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 61919-0818-30 (61919081830)
| NDC Package Code | 61919-818-30 |
|---|---|
| Billing NDC | 61919081830 |
| Package | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (61919-818-30) |
| Marketing Start Date | 2019-05-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |