Tapentadol Hydrochloride NDC 42806-627

NDC codes

FDA NDC Directory

Product NDC (as listed)42806-627Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42806-0627Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
42806-627-01	42806062701	100 TABLET, FILM COATED in 1 BOTTLE (42806-627-01)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 — 75 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: EPIC PHARMA LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214378
Marketing start: Dec 31, 2021
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 42806-627_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

N442806062701 followed by a unit qualifier and the quantity

Package 42806-0627-01. 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 Jan 28, 2026. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214378

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214378
Product	Strength	Form · route	Labeler	Product NDC
Tapentadol Hydrochloride	Tapentadol hydrochloride 50 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-626
Tapentadol Hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-628