Prescription drug · ANDA
Methotrexate NDC 71335-1772
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1772-1 | 71335177201 | 30 TABLET in 1 BOTTLE (71335-1772-1)Marketed from Dec 29, 2021 | |
| 71335-1772-2 | 71335177202 | 12 TABLET in 1 BOTTLE (71335-1772-2)Marketed from Dec 29, 2021 | |
| 71335-1772-3 | 71335177203 | 20 TABLET in 1 BOTTLE (71335-1772-3)Marketed from Dec 29, 2021 | |
| 71335-1772-4 | 71335177204 | 100 TABLET in 1 BOTTLE (71335-1772-4)Marketed from Dec 29, 2021 | |
| 71335-1772-5 | 71335177205 | 36 TABLET in 1 BOTTLE (71335-1772-5)Marketed from Dec 29, 2021 | |
| 71335-1772-6 | 71335177206 | 24 TABLET in 1 BOTTLE (71335-1772-6)Marketed from Jan 21, 2021 | |
| 71335-1772-7 | 71335177207 | 90 TABLET in 1 BOTTLE (71335-1772-7)Marketed from Dec 29, 2021 | |
| 71335-1772-8 | 71335177208 | 4 TABLET in 1 BOTTLE (71335-1772-8)Marketed from Dec 29, 2021 |
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 213343
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1772_17125571-6b01-40cb-ab78-7b9f4f8cc16cSPL ID 17125571-6b01-40cb-ab78-7b9f4f8cc16cSPL set ID 4741a44f-0d0b-4380-84f6-231a8d1560fbRxCUI 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
N471335177201followed by a unit qualifier and the quantityPackage 71335-1772-01. 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 is 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 is indicated for the: Methotrexate Tablets is indicated for the: treatment o…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213343
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 | Proficient Rx LP | 82804-136 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1524 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-486 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3991 |