Prescription drug · ANDA
Tramadol Hydrochloride NDC 80425-0548
Tramadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0548-1 | 80425054801 | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-1)Marketed from Aug 27, 2025 | |
| 80425-0548-2 | 80425054802 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-2)Marketed from Aug 27, 2025 | |
| 80425-0548-3 | 80425054803 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-3)Marketed from Aug 27, 2025 | |
| 80425-0548-4 | 80425054804 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-4)Marketed from Aug 27, 2025 | |
| 80425-0548-5 | 80425054805 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-5)Marketed from Aug 27, 2025 | |
| 80425-0548-6 | 80425054806 | 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-6)Marketed from Aug 27, 2025 | |
| 80425-0548-7 | 80425054807 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-7)Marketed from Aug 27, 2025 | |
| 80425-0548-8 | 80425054808 | 240 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0548-8)Marketed from Aug 27, 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, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211825
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 80425-0548_4641b78d-bdc6-12d5-e063-6394a90a728aSPL ID 4641b78d-bdc6-12d5-e063-6394a90a728aSPL set ID 3d719560-7449-f970-e063-6294a90a9bd8RxCUI 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
N480425054801followed by a unit qualifier and the quantityPackage 80425-0548-01. 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 211825
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, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4035 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4040 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Unichem Pharmaceuticals (USA), Inc. | 29300-355 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 87063-117 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5789 |
| Tramadol Hydrochloride | Tramadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5790 |