Prescription drug · NDA
ConZip (tramadol hydrochloride) NDC 68025-073
Tramadol hydrochloride 300 mg/1 · Capsule, Extended release · Oral · Vertical Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68025-073-30 | 68025007330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (68025-073-30)Marketed from Sep 20, 2011 |
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)
- ConZip
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022370
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68025-073_50c36ee9-b6f1-4f50-a276-cfbfa49ba588SPL ID 50c36ee9-b6f1-4f50-a276-cfbfa49ba588SPL set ID a65b4d05-3a1c-4aa1-848a-d20ac9aaf62fRxCUI 1148478, 1148482, 1148485, 1148487, 1148489, 1148491UNII 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
N468025007330followed by a unit qualifier and the quantityPackage 68025-0073-30. 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)
CONZIP is 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. CONZIP is 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. ( 1 ) 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 analgesics, including CONZIP, for use in patients for whom alternative treatment …
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| 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 |
| Tramadol Hydrochloride Extended-Releasetramadol hydrochloride | Tramadol hydrochloride 300 mg/1 | CapsuleOral | Trigen Laboratories, LLC | 13811-691 |
| ConZiptramadol hydrochloride | Tramadol hydrochloride 200 mg/1 | Capsule, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-072 |
| ConZiptramadol hydrochloride | Tramadol hydrochloride 100 mg/1 | Capsule, Extended releaseOral | Vertical Pharmaceuticals, LLC | 68025-071 |