Prescription drug · NDA
Nucynta (tapentadol hydrochloride) NDC 24510-050
Tapentadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Collegium Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24510-050-01 | 24510005001 | 10 BLISTER PACK in 1 CARTON (24510-050-01) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 1, 2019 | |
| 24510-050-10 | 24510005010 | 100 TABLET, FILM COATED in 1 BOTTLE (24510-050-10)Marketed from Apr 1, 2019 |
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)
- Nucynta
- Generic name (nonproprietary)
- tapentadol hydrochloride
- Active ingredients
- Tapentadol hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022304
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 24510-050_3f155622-a850-4d63-9539-9e645a8fcc28SPL ID 3f155622-a850-4d63-9539-9e645a8fcc28SPL set ID 80938c30-9fe3-4c7d-9d9c-5476638cfb2dRxCUI 825409, 825411, 825413, 854140, 854142, 854144UNII 71204KII53UPC 0324510075106, 0324510100105, 0324510050103
- 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
N424510005001followed by a unit qualifier and the quantityPackage 24510-0050-01. 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)
NUCYNTA (tapentadol) tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40kg. NUCYNTA tablets are an opioid analgesic indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults and pediatric patients aged 6 years and older with a body weight of at least 40 kg. ( 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022304
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 75 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0943 |
| Nucyntatapentadol hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | Collegium Pharmaceutical, Inc. | 24510-075 |
| Nucyntatapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Collegium Pharmaceutical, Inc. | 24510-100 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0945 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0942 |