Prescription drug · ANDA
Tapentadol Hydrochloride NDC 42806-626
Tapentadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · EPIC PHARMA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-626-01 | 4280606260142806062601 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-626-01)Marketed from Dec 31, 2021 |
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)
- Tapentadol Hydrochloride
- Generic name (nonproprietary)
- tapentadol hydrochloride
- Active ingredients
- Tapentadol hydrochloride — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- EPIC PHARMA LLCNDC labeler code 42806
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214378
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42806-626_120aa46b-8c91-4460-8e91-85cbaac53d20SPL ID 120aa46b-8c91-4460-8e91-85cbaac53d20SPL set ID fecd2104-5bf3-47ed-a6f0-5c6ebb0a17b4RxCUI 825409, 825411, 825413UNII 71204KII53UPC 0342806628010, 0342806626016, 0342806627013
- 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
N442806062601followed by a unit qualifier and the quantityPackage 42806-0626-01. 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)
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. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration [see Warnings and Precautions (5.1 )], and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. How…
Excerpt only. Read the full label for complete information.
About NDC 42806-626
- What is NDC 42806-626?
- 42806-626 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by EPIC PHARMA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tapentadol Hydrochloride.
- What is the active ingredient?
- Tapentadol hydrochloride.
- Who is the labeler?
- EPIC PHARMA LLC, NDC labeler code 42806. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tapentadol Hydrochloride?
- 9 other product NDCs are listed under this name. See all Tapentadol Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tapentadol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tapentadol Hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-081 | 73190-0081-01 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-082 | 73190-0082-01 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-083 | 73190-0083-01 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-369 | 72205-0369-91 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-370 | 72205-0370-91 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-371 | 72205-0371-91 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 20 mg/mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-801 | 70954-0801-1070954-0801-20 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-627 | 42806-0627-01 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-628 | 42806-0628-01 |
Other NDCs under ANDA 214378
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 |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-627 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-628 |