Prescription drug · ANDA
Tramadol Hydrochloride NDC 71335-9670
Tramadol hydrochloride 300 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9670-1 | 71335967001 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-1)Marketed from Mar 24, 2023 | |
| 71335-9670-2 | 71335967002 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-2)Marketed from Apr 13, 2026 | |
| 71335-9670-3 | 71335967003 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-3)Marketed from Jan 6, 2026 | |
| 71335-9670-4 | 71335967004 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9670-4)Marketed from Apr 13, 2026 |
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 — 300 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200503
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 71335-9670_e0a37ad2-9bb4-4c7c-9fc6-24b0fc7f836fSPL ID e0a37ad2-9bb4-4c7c-9fc6-24b0fc7f836fSPL set ID acd5d8e0-a4cc-4654-ae04-faff347a60caRxCUI 833713UNII 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
N471335967001followed by a unit qualifier and the quantityPackage 71335-9670-01. 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 extended-release tablet 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. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosages or duration, and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , 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 o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 200503
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 300 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-5078 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Medsource Pharmaceuticals | 45865-184 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-0886 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-697 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-0942 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 72189-154 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-698 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1527 |
| Tramadol Hydrochloride | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-699 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7601 |
| Tramadol HCL ER | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 72189-521 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-463 |
| Tramadol HCL ERtramadol hcl | Tramadol hydrochloride 300 mg/1 | Tablet, Extended releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0312 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-468 |
| Tramadol HCl ERtramadol hcl | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | DIRECT RX | 61919-818 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Quality Care Products, LLC | 83008-009 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-8367 |
| Tramadol Hydrochloride | Tramadol hydrochloride 200 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-537 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Asclemed USA, Inc. | 76420-536 |
| Tramadol Hydrochloride | Tramadol hydrochloride 100 mg/1 | Tablet, Extended releaseOral | Lupin Pharmaceuticals, Inc. | 68180-383 |
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