What is NDC 42806-627?

42806-627 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 75 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	4280606270142806062701	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 LLCNDC labeler code 42806
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)

About NDC 42806-627

What is NDC 42806-627?: 42806-627 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 75 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Tapentadol Hydrochloride NDCs
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 50 mg/1	Tablet, Film coatedOral	EPIC PHARMA LLC	42806-626	42806-0626-01
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.

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