Prescription drug · ANDA
Levorphanol Tartrate NDC 0406-2224
Levorphanol tartrate 2 mg/1 · Tablet · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0406-2224-01 | 00406222401 | 100 TABLET in 1 BOTTLE, PLASTIC (0406-2224-01)Marketed from Dec 13, 2019 |
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)
- Levorphanol Tartrate
- Generic name (nonproprietary)
- levorphanol tartrate
- Active ingredients
- Levorphanol tartrate — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SpecGx LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212024
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0406-2224_72cc6b5a-55a3-405c-bf1d-c8810077aa21SPL ID 72cc6b5a-55a3-405c-bf1d-c8810077aa21SPL set ID 759c7040-0be0-4d17-be97-e467e423eaa8RxCUI 197873UNII 04WQU6T9QI
- 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
N400406222401followed by a unit qualifier and the quantityPackage 00406-2224-01. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 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 ), reserve opioid analgesics, including Levorphanol Tartrate Tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Excerpt only. Read the full label for complete information.