Prescription drug · ANDA
Levoleucovorin Calcium (Levoleucovorin injection) NDC 14335-341
Levoleucovorin calcium 10 mg/1 · Injection, Solution · Intravenous · Hainan Poly Pharm. Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14335-341-01 | 1433503410114335034101 | 1 VIAL in 1 CARTON (14335-341-01) / 25 INJECTION, SOLUTION in 1 VIALMarketed from May 31, 2023 |
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)
- Levoleucovorin Calcium
- Generic name (nonproprietary)
- levoleucovorin injection
- Active ingredients
- Levoleucovorin calcium — 10 mg/1
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Hainan Poly Pharm. Co., Ltd.NDC labeler code 14335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217314
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid (Chemical structure)
- Identifiers
- Product ID 14335-341_fcf83646-5cb1-2844-e053-6294a90a8a92SPL ID fcf83646-5cb1-2844-e053-6294a90a8a92SPL set ID c10b0c18-dd7c-4a76-a79b-b8d38a08ab87RxCUI 1720765, 1720773UNII 778XL6VBS8UPC 0314335340015, 0314335341012
- Pharmacologic class
- Folate Analog
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N414335034101followed by a unit qualifier and the quantityPackage 14335-0341-01. 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 .
Indications (excerpt from the label)
Levoleucovorin injection is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination in adult and pediatric patients. the treatment of adults with metastatic colorectal cancer in combination with fluorouracil. Limitations of Use: Levoleucovorin injection is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B 12 , because of the risk of progression of neurologic manifestations despite hematologic remission. Levoleucovorin injection is a folate analog indicated for: Rescue after high-d…
Excerpt only. Read the full label for complete information.
About NDC 14335-341
- What is NDC 14335-341?
- 14335-341 is the product NDC for Levoleucovorin Calcium (levoleucovorin injection), Levoleucovorin calcium 10 mg/1 injection, solution, listed with the FDA by Hainan Poly Pharm. Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levoleucovorin Calcium (Levoleucovorin injection).
- What is the active ingredient?
- Levoleucovorin calcium.
- Who is the labeler?
- Hainan Poly Pharm. Co., Ltd., NDC labeler code 14335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levoleucovorin Calcium?
- 4 other product NDCs are listed under this name. See all Levoleucovorin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levoleucovorin Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Slate Run Pharmaceuticals | 70436-209 | 70436-0209-80 |
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Slate Run Pharmaceuticals | 70436-210 | 70436-0210-80 |
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-340 | 14335-0340-01 |
| Levoleucovorin Calciumlevoleucovorin | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals LLC | 70121-1572 | 70121-1572-01 |
Other NDCs under ANDA 217314
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 |
|---|---|---|---|---|
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Hainan Poly Pharm. Co., Ltd. | 14335-340 |
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Slate Run Pharmaceuticals | 70436-209 |
| Levoleucovorin Calciumlevoleucovorin injection | Levoleucovorin calcium 10 mg/mL | Injection, SolutionIntravenous | Slate Run Pharmaceuticals | 70436-210 |