Prescription drug · ANDA
Tramadol Hydrochloride NDC 72189-154
Tramadol hydrochloride 200 mg/1 · Tablet, Extended release · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-154-30 | 72189015430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-154-30)Marketed from Nov 10, 2020 | |
| 72189-154-60 | 72189015460 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-154-60)Marketed from Nov 10, 2020 |
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 — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- DIRECT RX
- 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 72189-154_2be91ca4-b100-8b02-e063-6294a90a3c24SPL ID 2be91ca4-b100-8b02-e063-6294a90a3c24SPL set ID b3c702f7-0a8c-a52b-e053-2995a90a6df3RxCUI 833711UNII 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
N472189015430followed by a unit qualifier and the quantityPackage 72189-0154-30. 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)
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 and Precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride extended-release …
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 | 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 300 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-9670 |
| 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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