Prescription drug · ANDA
Tapentadol Hydrochloride NDC 73190-081
Tapentadol hydrochloride 50 mg/1 · Tablet, Film coated · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-081-01 | 7319000810173190008101 | 100 TABLET, FILM COATED in 1 BOTTLE (73190-081-01)Marketed from Sep 14, 2026 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AvKARENDC labeler code 73190
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220865
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 73190-081_5b769a8c-f810-3f17-e063-6294a90a2cedSPL ID 5b769a8c-f810-3f17-e063-6294a90a2ced
- 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
N473190008101followed by a unit qualifier and the quantityPackage 73190-0081-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 73190-081
- What is NDC 73190-081?
- 73190-081 is the product NDC for Tapentadol Hydrochloride, Tapentadol hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by AvKARE. 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?
- AvKARE, NDC labeler code 73190. 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.
Related NDCs: other Tapentadol Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 75 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-627 | 42806-0627-01 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | EPIC PHARMA LLC | 42806-628 | 42806-0628-01 |
Other NDCs under ANDA 220865
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 |
|---|---|---|---|---|
| Tapentadol Hydrochloride | Tapentadol hydrochloride 50 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-369 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-370 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-371 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 75 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-082 |
| Tapentadol Hydrochloride | Tapentadol hydrochloride 100 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-083 |