Prescription drug · ANDA
Methotrexate NDC 71335-1118
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1118-1 | 71335111801 | 30 TABLET in 1 BOTTLE (71335-1118-1)Marketed from Feb 25, 2019 | |
| 71335-1118-2 | 71335111802 | 12 TABLET in 1 BOTTLE (71335-1118-2)Marketed from May 17, 2024 | |
| 71335-1118-3 | 71335111803 | 20 TABLET in 1 BOTTLE (71335-1118-3)Marketed from May 17, 2024 | |
| 71335-1118-4 | 71335111804 | 100 TABLET in 1 BOTTLE (71335-1118-4)Marketed from May 17, 2024 | |
| 71335-1118-5 | 71335111805 | 36 TABLET in 1 BOTTLE (71335-1118-5)Marketed from May 17, 2024 | |
| 71335-1118-6 | 71335111806 | 24 TABLET in 1 BOTTLE (71335-1118-6)Marketed from May 17, 2024 | |
| 71335-1118-7 | 71335111807 | 90 TABLET in 1 BOTTLE (71335-1118-7)Marketed from May 17, 2024 | |
| 71335-1118-8 | 71335111808 | 4 TABLET in 1 BOTTLE (71335-1118-8)Marketed from May 17, 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)
- Methotrexate
- Generic name (nonproprietary)
- methotrexate
- Active ingredients
- Methotrexate sodium — 2.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081235
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1118_196573c3-e357-4a59-a2bd-2416944fa38aSPL ID 196573c3-e357-4a59-a2bd-2416944fa38aSPL set ID 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1RxCUI 105585UNII 3IG1E710ZN
- 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
N471335111801followed by a unit qualifier and the quantityPackage 71335-1118-01. 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)
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 are indicated for the: • treatment of adul…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 081235
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 | Mylan Institutional Inc. | 51079-670 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-121 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 0378-0014 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-065 |