Prescription drug · ANDA
Tapentadol Hydrochloride NDC 70954-801
Tapentadol hydrochloride 20 mg/mL · Solution · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-801-10 | 70954080110 | 1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLEMarketed from Jul 13, 2026 | |
| 70954-801-20 | 70954080120 | 1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLEMarketed from Jul 13, 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 — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219119
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70954-801_38c1235a-d675-4b2d-b1a5-100427af2364SPL ID 38c1235a-d675-4b2d-b1a5-100427af2364SPL set ID e0ecb809-6a55-4afe-b981-b8f174e5c344RxCUI 1356315UNII 71204KII53UPC 0370954801108, 0370954801207
- 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
N470954080110followed by a unit qualifier and the quantityPackage 70954-0801-10. 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 hydrochloride oral solution is 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 dosage or duration and persist over the course of therapy, [see Warnings and Precautions (5.2)] , reserve opioid analgesics, including tapentadol hydrochloride oral solution 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 Ph…
Excerpt only. Read the full label for complete information.