Prescription drug · ANDA
Tramadol Hydrochloride NDC 47335-537
Tramadol hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-537-08 | 47335053708 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-08)Marketed from Dec 30, 2011 | |
| 47335-537-18 | 47335053718 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-18)Marketed from Dec 30, 2011 | |
| 47335-537-83 | 47335053783 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-83)Marketed from Dec 30, 2011 | |
| 47335-537-88 | 47335053788 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47335-537-88)Marketed from Dec 30, 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)
- Tramadol Hydrochloride
- Generic name (nonproprietary)
- tramadol hydrochloride
- Active ingredients
- Tramadol hydrochloride — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- 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 47335-537_e080bc94-c122-41f3-8bda-0fb9318f8aa6SPL ID e080bc94-c122-41f3-8bda-0fb9318f8aa6SPL set ID dc420d50-6192-482d-b3da-3be55870a79aRxCUI 1946525, 1946527, 1946529UNII 9N7R477WCKUPC 0347335533835, 0347335537833, 0347335531831
- 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
N447335053708followed by a unit qualifier and the quantityPackage 47335-0537-08. 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 Tramadol hydrochloride extended-release tablets 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. 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 [see Warnings] , reserve opioid analgesics, including tramadol hydrochloride extended-release tablets, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management…
Excerpt only. Read the full label for complete information.
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 200 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-533 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-531 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0127 |