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NDC 59651-0441-01 Tramadol Hydrochloride 50 mg/1 Details
Tramadol Hydrochloride 50 mg/1
Tramadol Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. 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: 59651-0441-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol
Product Information
| NDC | 59651-0441 |
|---|---|
| Product ID | 59651-441_25d243f2-4969-4aae-956a-9ed9247ab487 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Tramadol Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Tramadol Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/1 |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | ANDA |
| Application Number | ANDA203494 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 59651-0441-01 (59651044101)
| NDC Package Code | 59651-441-01 |
|---|---|
| Billing NDC | 59651044101 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (59651-441-01) |
| Marketing Start Date | 2020-09-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |