Prescription drug · NDA AUTHORIZED GENERIC
Tapentadol (tapentadol hydrochloride) NDC 0054-0940
Tapentadol hydrochloride 250 mg/1 · Tablet, Film coated, Extended release · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0940-21 | 00054094021 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0940-21)Marketed from Dec 15, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tapentadol
- Generic name (nonproprietary)
- tapentadol hydrochloride
- Active ingredients
- Tapentadol hydrochloride — 250 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 200533
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-0940_7fef46e2-c049-44d8-962f-fdd233dad041SPL ID 7fef46e2-c049-44d8-962f-fdd233dad041SPL set ID 38de863e-56ff-4c43-9ab8-9b3e1ba82858RxCUI 1148797, 1148800, 1148803, 1148807, 1148809UNII 71204KII53UPC 0300540936211, 0300540940218, 0300540938215, 0300540939212, 0300540937218
- 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
N400054094021followed by a unit qualifier and the quantityPackage 00054-0940-21. 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)
Tapentadol extended-release tablets are indicated for the management of: Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opio…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 200533
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 |
|---|---|---|---|---|
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0937 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0938 |
| Nucynta ERtapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coated, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-058 |
| Nucynta ERtapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-116 |
| Nucynta ERtapentadol hydrochloride | Tapentadol hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-232 |
| Nucynta ERtapentadol hydrochloride | Tapentadol hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-174 |
| Nucynta ERtapentadol hydrochloride | Tapentadol hydrochloride 250 mg/1 | Tablet, Film coated, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-291 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0936 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0939 |