Prescription drug · ANDA
Tramadol HCL ER (Tramadol hcl) NDC 80425-0127
Tramadol hydrochloride 200 mg/1 · Tablet, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0127-1 | 8042501270180425012701 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-1)Marketed from Dec 30, 2011 | |
| 80425-0127-2 | 8042501270280425012702 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0127-2)Marketed from Dec 30, 2011 |
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 HCL ERSuffix: ER
- Generic name (nonproprietary)
- tramadol hcl
- Active ingredients
- Tramadol hydrochloride — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091607
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 80425-0127_2a99a7c1-c4ba-2b01-e063-6294a90aa3b8SPL ID 2a99a7c1-c4ba-2b01-e063-6294a90aa3b8SPL set ID bba287fe-fbf6-65a9-e053-2a95a90a9237RxCUI 1946527UNII 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
N480425012701followed by a unit qualifier and the quantityPackage 80425-0127-01. 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)
Indications and Usage Section INDICATIONS AND USAGE Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see WARNINGS], reserve tramadol hydrochloride extended-release tablets or use in patients for whom alternative treatment options [e.g., non-opioid analgesics or immediate-release opioids], are ineffective, not …
Excerpt only. Read the full label for complete information.
About NDC 80425-0127
- What is NDC 80425-0127?
- 80425-0127 is the product NDC for Tramadol HCL ER (tramadol hcl), Tramadol hydrochloride 200 mg/1 tablet, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tramadol HCL ER (Tramadol HCL).
- What is the active ingredient?
- Tramadol hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tramadol HCL ER?
- 6 other product NDCs are listed under this name. See all Tramadol HCL ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tramadol HCL ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tramadol HCL ER | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-521 | 72189-0521-30 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0312 | 80425-0312-0180425-0312-0280425-0312-03 |
| Tramadol HCl ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 61919-818 | 61919-0818-3061919-0818-6061919-0818-90 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0108 | 80425-0108-0180425-0108-0280425-0108-03 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0136 | 80425-0136-0180425-0136-02 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0141 | 80425-0141-0180425-0141-0280425-0141-03 |
Other NDCs under ANDA 091607
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 100 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-531 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-533 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-537 |