Prescription drug · NDA
Nucynta ER (tapentadol hydrochloride) NDC 24510-232
Tapentadol hydrochloride 200 mg/1 · Tablet, Film coated, Extended release · Oral · Collegium Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24510-232-01 | 24510023201 | 10 BLISTER PACK in 1 CARTON (24510-232-01) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 19, 2019 | |
| 24510-232-60 | 24510023260 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24510-232-60)Marketed from Apr 19, 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 ERSuffix: ER
- Generic name (nonproprietary)
- tapentadol hydrochloride
- Active ingredients
- Tapentadol hydrochloride — 200 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 200533
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 24510-232_2d370c0d-8d66-446f-be46-ed92e0f1cf6bSPL ID 2d370c0d-8d66-446f-be46-ed92e0f1cf6bSPL set ID c3d04d70-0155-4147-9ce4-a3b1fad4b373RxCUI 1148797, 1148800, 1148803, 1148807, 1148809, 1149367, 1149370, 1149373, 1149376, 1149378UNII 71204KII53UPC 0324510058604, 0324510116601, 0324510174601, 0324510232608, 0324510291605
- 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
N424510023201followed by a unit qualifier and the quantityPackage 24510-0232-01. 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 ER (tapentadol) is indicated for the management of: Severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. NUCYNTA ER is an opioid agonist indicated for the management of: severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opi…
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 250 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0940 |
| 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 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 |