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NDC 68134-0402-40 tramadol hydrochloride 5 mg/mL Details
tramadol hydrochloride 5 mg/mL
tramadol hydrochloride is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Palmetto Pharmaceuticals, Inc.. 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: 68134-0402-40Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Tramadol
Product Information
| NDC | 68134-0402 |
|---|---|
| Product ID | 68134-402_0d083748-6330-274a-e063-6294a90a943e |
| Associated GPIs | 65100095102005 |
| GCN Sequence Number | 081474 |
| GCN Sequence Number Description | tramadol HCl SOLUTION 5 MG/ML ORAL |
| HIC3 | H3A |
| HIC3 Description | OPIOID ANALGESICS |
| GCN | 48598 |
| 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 | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/mL |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Labeler Name | Palmetto Pharmaceuticals, Inc. |
| Pharmaceutical Class | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CIV |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA214044 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68134-0402-40 (68134040240)
| NDC Package Code | 68134-402-40 |
|---|---|
| Billing NDC | 68134040240 |
| Package | 4 TRAY in 1 CASE (68134-402-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68134-402-05) |
| Marketing Start Date | 2021-09-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |