Prescription drug · ANDA
Methotrexate NDC 0555-0572
Methotrexate sodium 2.5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0555-0572-02 | 0055505720200555057202 | 100 TABLET in 1 BOTTLE (0555-0572-02)Marketed from Nov 1, 1990 | |
| 0555-0572-35 | 0055505723500555057235 | 36 TABLET in 1 BOTTLE (0555-0572-35)Marketed from Nov 1, 1990 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0555
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 081099
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 0555-0572_9c7cf5a6-e720-4e83-bb08-f371e9bb9c9eSPL ID 9c7cf5a6-e720-4e83-bb08-f371e9bb9c9eSPL set ID 9b34b1d8-d125-41a2-9f6f-3fab67b573bdRxCUI 105585UNII 3IG1E710ZNUPC 0305550572350
- 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
N400555057202followed by a unit qualifier and the quantityPackage 00555-0572-02. 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 adults and pediatr…
Excerpt only. Read the full label for complete information.
About NDC 0555-0572
- What is NDC 0555-0572?
- 0555-0572 is the product NDC for Methotrexate, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methotrexate.
- What is the active ingredient?
- Methotrexate sodium.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0555. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methotrexate?
- 51 other product NDCs are listed under this name. See all Methotrexate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methotrexate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Methotrexate | Methotrexate 2.5 mg/1 | TabletOral | American Health Packaging | 60687-975 | 60687-0975-94 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-711 | 46708-0711-05 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Alembic Pharmaceuticals Limited | 46708-712 | 46708-0712-01 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-711 | 62332-0711-05 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Alembic Pharmaceuticals Inc. | 62332-712 | 62332-0712-01 |
| Methotrexate | Methotrexate 2.5 mg/1 | TabletOral | AvPAK | 50268-554 | 50268-0554-15 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Safecor Health LLC | 48433-065 | 48433-0065-05 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Coupler LLC | 67046-1524 | 67046-1524-03 |
| Methotrexate | Methotrexate sodium 25 mg/mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Hospira, Inc. | 61703-161 | 61703-0161-05 |
| Methotrexate | Methotrexate sodium 50 mg/2mL | Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous | Eugia US LLC | 55150-510 | 55150-0510-0155150-0510-05 |
Other NDCs under ANDA 081099
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 | AvKARE | 42291-594 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5457 |
| Methotrexate | Methotrexate sodium 2.5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0782 |