Prescription drug · ANDA
Methotrexate NDC 62135-772
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-772-35 | 62135077235 | 36 TABLET in 1 BOTTLE (62135-772-35)Marketed from Aug 29, 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)
- Methotrexate
- Generic name (nonproprietary)
- methotrexate
- Active ingredients
- Methotrexate sodium — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210454
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-772_462a5023-e5a1-692a-e063-6294a90a7236SPL ID 462a5023-e5a1-692a-e063-6294a90a7236SPL set ID 2609da8f-80dc-448e-8eba-35d11488ce7fRxCUI 105585UNII 3IG1E710ZNUPC 0362135772352
- Pharmacologic class
- Folate Analog Metabolic Inhibitor
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
N462135077235followed by a unit qualifier and the quantityPackage 62135-0772-35. 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)
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate tablets areindicated for the: treatment of adults and pediatri…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210454
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 |
|---|---|---|---|---|
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2221 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3765 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-182 |