Tapentadol (tapentadol hydrochloride) NDC 0054-0942

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0942Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0942Add 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
0054-0942-25	00054094225	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25)Marketed from Dec 15, 2025

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): tapentadol hydrochloride
Active ingredients: Tapentadol hydrochloride — 50 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 022304
Marketing start: Dec 15, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0942_7f43eb28-160b-4256-bde1-ed711407ad01SPL ID 7f43eb28-160b-4256-bde1-ed711407ad01SPL set ID 863f3fd3-1e8d-41b0-855f-8f9a29237cdaRxCUI 825409, 825411, 825413UNII 71204KII53UPC 0300540942250, 0300540945251
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

N400054094225 followed by a unit qualifier and the quantity

Package 00054-0942-25. 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 Feb 26, 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 and pediatric patients aged 6 years and older with a body weight of at least 40kg. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dose or duration [see Warnings and Precautions (5.1) ] , reserve tapentadol tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 022304

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

FDA NDC Directory listings under NDA 022304
Product	Strength	Form · route	Labeler	Product NDC
Nucyntatapentadol hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	Collegium Pharmaceutical, Inc.	24510-100
Nucyntatapentadol hydrochloride	Tapentadol hydrochloride 50 mg/1	Tablet, Film coatedOral	Collegium Pharmaceutical, Inc.	24510-050
Nucyntatapentadol hydrochloride	Tapentadol hydrochloride 75 mg/1	Tablet, Film coatedOral	Collegium Pharmaceutical, Inc.	24510-075
Tapentadoltapentadol hydrochloride	Tapentadol hydrochloride 75 mg/1	Tablet, Film coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0943
Tapentadoltapentadol hydrochloride	Tapentadol hydrochloride 100 mg/1	Tablet, Film coatedOral	Hikma Pharmaceuticals USA Inc.	0054-0945