Prescription drug · ANDA
Levorphanol Tartrate NDC 63629-2093
Levorphanol tartrate 2 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2093-1 | 6362920930163629209301 | 100 TABLET in 1 BOTTLE (63629-2093-1)Marketed from Aug 8, 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 63629
- 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 63629-2093_46b0156b-828d-4997-bc71-e4e5471b9883SPL ID 46b0156b-828d-4997-bc71-e4e5471b9883SPL set ID d7587868-561c-4e04-b02c-36a4b653a762RxCUI 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
N463629209301followed by a unit qualifier and the quantityPackage 63629-2093-01. 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, which can occur at any dosage or duration [see WARNINGS ] , reserve levorphanol tartrate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Levorphanol tartrate tablets should not be used for an extended period of time unless t…
Excerpt only. Read the full label for complete information.
About NDC 63629-2093
- What is NDC 63629-2093?
- 63629-2093 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 63629. 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 2 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2309 | 72162-2309-01 |
| 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 | Hikma Pharmaceuticals USA Inc. | 0054-0438 | 00054-0438-25 |
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 3 mg/1 | TabletOral | Lannett Company, Inc. | 0527-3237 |