Tapentadol (tapentadol hydrochloride) NDC 0054-0938

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0938Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0938Add 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
0054-0938-21	00054093821	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0938-21)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 — 150 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 200533
Marketing start: Dec 15, 2025
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0938_7fef46e2-c049-44d8-962f-fdd233dad041SPL ID 7fef46e2-c049-44d8-962f-fdd233dad041SPL set ID 38de863e-56ff-4c43-9ab8-9b3e1ba82858RxCUI 1148797, 1148800, 1148803, 1148807, 1148809UNII 71204KII53UPC 0300540936211, 0300540940218, 0300540938215, 0300540939212, 0300540937218
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

N400054093821 followed by a unit qualifier and the quantity

Package 00054-0938-21. 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 extended-release tablets are indicated for the management of: Severe and persistent pain in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Severe and persistent neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release/long-acting opio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 200533

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

FDA NDC Directory listings under NDA 200533
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
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 200 mg/1	Tablet, Film coated, Extended releaseOral	Collegium Pharmaceutical, Inc.	24510-232
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