Prescription drug · ANDA
Levorphanol Tartrate NDC 72162-2309
Levorphanol tartrate 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2309-1 | 7216223090172162230901 | 100 TABLET in 1 BOTTLE (72162-2309-1)Marketed from May 7, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch PrepackNDC labeler code 72162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211484
- Marketing start
- Marketing end
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72162-2309_8fca6bcc-4c5c-42d5-9023-5d090bd57a65SPL ID 8fca6bcc-4c5c-42d5-9023-5d090bd57a65SPL set ID deed8652-9b9d-48b4-8c3e-9fdd7c46237eRxCUI 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
N472162230901followed by a unit qualifier and the quantityPackage 72162-2309-01. 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, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Levorphanol Tartrate 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 adequate analgesia
Excerpt only. Read the full label for complete information.
About NDC 72162-2309
- What is NDC 72162-2309?
- 72162-2309 is the product NDC for Levorphanol Tartrate, Levorphanol tartrate 2 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levorphanol Tartrate.
- What is the active ingredient?
- Levorphanol tartrate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 72162. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levorphanol Tartrate?
- 9 other product NDCs are listed under this name. See all Levorphanol Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levorphanol Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | ACERTIS PHARMACEUTICALS, LLC | 72989-417 | 72989-0417-10 |
| Levorphanol Tartrate | Levorphanol tartrate 3 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-058 | 57664-0058-88 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-762 | 57664-0762-88 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Virtus Pharmaceuticals, LLC | 69543-417 | 69543-0417-10 |
| Levorphanol Tartrate | Levorphanol tartrate 3 mg/1 | TabletOral | Lannett Company, Inc. | 0527-3237 | 00527-3237-37 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | SpecGx LLC | 0406-2224 | 00406-2224-01 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Lannett Company, Inc. | 0527-3236 | 00527-3236-37 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2093 | 63629-2093-01 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0054-0438 | 00054-0438-25 |
Other NDCs under ANDA 211484
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 | Virtus Pharmaceuticals, LLC | 69543-417 |
| Levorphanol Tartrate | Levorphanol tartrate 2 mg/1 | TabletOral | ACERTIS PHARMACEUTICALS, LLC | 72989-417 |