Prescription drug · NDA AUTHORIZED GENERIC
Tramadol Hydrochloride Extended-Release (Tramadol hydrochloride) NDC 13811-691
Tramadol hydrochloride 300 mg/1 · Capsule · Oral · Trigen Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13811-691-30 | 1381106913013811069130 | 30 CAPSULE in 1 BOTTLE, PLASTIC (13811-691-30)Marketed from Jun 22, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Trigen Laboratories, LLCNDC labeler code 13811
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022370
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 13811-691_0e535876-333d-4ac4-8cdf-847613083c06SPL ID 0e535876-333d-4ac4-8cdf-847613083c06SPL set ID c0bc7218-3fd0-4646-96f4-25355fc84aa9RxCUI 1148478, 1148485, 1148489UNII 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
N413811069130followed by a unit qualifier and the quantityPackage 13811-0691-30. 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 Extended-Release Capsules are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Tramadol Hydrochloride Extended-Release Capsules are an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid a…
Excerpt only. Read the full label for complete information.
About NDC 13811-691
- What is NDC 13811-691?
- 13811-691 is the product NDC for Tramadol Hydrochloride Extended-Release, Tramadol hydrochloride 300 mg/1 capsule, listed with the FDA by Trigen Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tramadol Hydrochloride Extended-Release (Tramadol hydrochloride).
- What is the active ingredient?
- Tramadol hydrochloride.
- Who is the labeler?
- Trigen Laboratories, LLC, NDC labeler code 13811. 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 Hydrochloride Extended-Release?
- 2 other product NDCs are listed under this name. See all Tramadol Hydrochloride Extended-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tramadol Hydrochloride Extended-Release 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 Hydrochloride Extended-Releasetramadol hydrochloride | Tramadol hydrochloride 100 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-689 | 13811-0689-30 |
| Tramadol Hydrochloride Extended-Releasetramadol hydrochloride | Tramadol hydrochloride 200 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-690 | 13811-0690-30 |
Other NDCs under NDA 022370
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 |
|---|---|---|---|---|
| ConZiptramadol hydrochloride | Tramadol hydrochloride 100 mg/1 | Capsule, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-071 |
| ConZiptramadol hydrochloride | Tramadol hydrochloride 200 mg/1 | Capsule, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-072 |
| ConZiptramadol hydrochloride | Tramadol hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-073 |
| Tramadol Hydrochloride Extended-Releasetramadol hydrochloride | Tramadol hydrochloride 100 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-689 |
| Tramadol Hydrochloride Extended-Releasetramadol hydrochloride | Tramadol hydrochloride 200 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-690 |