Prescription drug · ANDA
Tramadol Hydrochloride NDC 80425-0501
Tramadol hydrochloride 50 mg/1 · Tablet, Coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0501-1 | 80425050101 | 15 TABLET, COATED in 1 BOTTLE (80425-0501-1)Marketed from Feb 13, 2025 | |
| 80425-0501-2 | 80425050102 | 30 TABLET, COATED in 1 BOTTLE (80425-0501-2)Marketed from Feb 13, 2025 | |
| 80425-0501-3 | 80425050103 | 60 TABLET, COATED in 1 BOTTLE (80425-0501-3)Marketed from Feb 13, 2025 | |
| 80425-0501-4 | 80425050104 | 90 TABLET, COATED in 1 BOTTLE (80425-0501-4)Marketed from Feb 13, 2025 | |
| 80425-0501-5 | 80425050105 | 120 TABLET, COATED in 1 BOTTLE (80425-0501-5)Marketed from Feb 13, 2025 | |
| 80425-0501-6 | 80425050106 | 40 TABLET, COATED in 1 BOTTLE (80425-0501-6)Marketed from Feb 13, 2025 | |
| 80425-0501-7 | 80425050107 | 180 TABLET, COATED in 1 BOTTLE (80425-0501-7)Marketed from Feb 13, 2025 | |
| 80425-0501-8 | 80425050108 | 240 TABLET, COATED in 1 BOTTLE (80425-0501-8)Marketed from Feb 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tramadol Hydrochloride
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 50 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076003
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 80425-0501_2e738ab3-ae9a-9416-e063-6394a90afc75SPL ID 2e738ab3-ae9a-9416-e063-6394a90afc75SPL set ID 2e738ced-9cde-e776-e063-6294a90a7e33RxCUI 835603UNII 9N7R477WCK
- Pharmacologic class
- Opioid Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425050101followed by a unit qualifier and the quantityPackage 80425-0501-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets should not …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076003
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals LLC | 65162-627 |
| Tramadol HCL | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Advanced Rx of Tennessee, LLC | 80425-0057 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Major Pharmaceuticals | 0904-7496 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Clinical Solutions Wholesale, LLC | 58118-2348 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals NY LLC | 60219-2348 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 63187-063 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | NuCare Pharmaceuticals,Inc. | 68071-4119 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1209 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | Amneal Pharmaceuticals NY LLC | 69238-2348 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, CoatedOral | American Health Packaging | 60687-795 |