Prescription drug · ANDA
Levorphanol Tartrate NDC 0527-3237
Levorphanol tartrate 3 mg/1 · Tablet · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-3237-37 | 00527323737 | 100 TABLET in 1 BOTTLE (0527-3237-37)Marketed from Jan 12, 2021 |
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 — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213479
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0527-3237_a0edf042-6bef-434f-bd7e-ca4a899c1841SPL ID a0edf042-6bef-434f-bd7e-ca4a899c1841SPL set ID a50debe1-90b3-4931-9ec0-67e88dd21b04RxCUI 197873, 2058845UNII 04WQU6T9QIUPC 0305273236379, 0305273237376
- 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
N400527323737followed by a unit qualifier and the quantityPackage 00527-3237-37. 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, includinglevorphanol, 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.
Other NDCs under ANDA 213479
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 |
|---|---|---|---|---|
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Lannett Company, Inc. | 0527-3236 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2093 |