Prescription drug · NDA AUTHORIZED GENERIC
Tapentadol (Tapentadol hydrochloride) NDC 0054-0945
Tapentadol hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0945-25 | 0005409452500054094525 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0945-25)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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022304
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0054-0945_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
N400054094525followed by a unit qualifier and the quantityPackage 00054-0945-25. 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 . 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.
About NDC 0054-0945
- What is NDC 0054-0945?
- 0054-0945 is the product NDC for Tapentadol (tapentadol hydrochloride), Tapentadol hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tapentadol (Tapentadol Hydrochloride).
- What is the active ingredient?
- Tapentadol hydrochloride.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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?
- 7 other product NDCs are listed under this name. See all Tapentadol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tapentadol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0936 | 00054-0936-21 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0937 | 00054-0937-21 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 150 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0938 | 00054-0938-21 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 200 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0939 | 00054-0939-21 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 250 mg/1 | Tablet, Film coated, Extended releaseOral | Hikma Pharmaceuticals USA Inc. | 0054-0940 | 00054-0940-21 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0942 | 00054-0942-25 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0943 | 00054-0943-25 |
Other NDCs under NDA 022304
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 |
|---|---|---|---|---|
| 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 |
| Nucyntatapentadol hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Collegium Pharmaceutical, Inc. | 24510-100 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0942 |
| Tapentadoltapentadol hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | Hikma Pharmaceuticals USA Inc. | 0054-0943 |