Methotrexate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Methotrexate Sodium.
| Product ID | 71335-1118_0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1 |
| NDC | 71335-1118 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Methotrexate |
| Generic Name | Methotrexate |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 1992-05-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA081235 |
| Labeler Name | Bryant Ranch Prepack |
| Substance Name | METHOTREXATE SODIUM |
| Active Ingredient Strength | 3 mg/1 |
| Pharm Classes | Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2021-09-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Marketing Category | ANDA |
| Application Number | ANDA081235 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-02-28 |
| Ingredient | Strength |
|---|---|
| METHOTREXATE SODIUM | 2.5 mg/1 |
| SPL SET ID: | 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1 |
| Manufacturer | |
| UNII |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9367 | Methotrexate | Methotrexate |
| 0143-9516 | Methotrexate | Methotrexate |
| 0143-9517 | Methotrexate | Methotrexate |
| 0143-9518 | Methotrexate | Methotrexate |
| 0143-9519 | Methotrexate | Methotrexate |
| 0143-9830 | Methotrexate | Methotrexate |
| 0378-0014 | Methotrexate | methotrexate |
| 0555-0572 | Methotrexate | Methotrexate |
| 0703-3671 | Methotrexate | Methotrexate |
| 0703-3675 | Methotrexate | Methotrexate |
| 0703-3678 | Methotrexate | Methotrexate |
| 68382-775 | Methotrexate | Methotrexate |
| 69238-1423 | Methotrexate | Methotrexate |
| 70518-0223 | METHOTREXATE | METHOTREXATE |
| 70518-1251 | Methotrexate | Methotrexate |
| 70518-1398 | Methotrexate | Methotrexate |
| 70771-1058 | Methotrexate | Methotrexate |
| 71335-0782 | Methotrexate | Methotrexate |
| 16729-277 | Methotrexate | Methotrexate |
| 21695-111 | Methotrexate | Methotrexate |
| 42291-594 | Methotrexate | Methotrexate |
| 42254-110 | METHOTREXATE | METHOTREXATE |
| 43063-439 | Methotrexate | Methotrexate |
| 47335-235 | Methotrexate | Methotrexate |
| 50090-0294 | METHOTREXATE | METHOTREXATE |
| 50090-2345 | Methotrexate | Methotrexate |
| 50090-3418 | Methotrexate | Methotrexate |
| 51079-670 | Methotrexate | Methotrexate |
| 51407-121 | Methotrexate | Methotrexate |
| 61703-350 | Methotrexate | Methotrexate |
| 61703-408 | Methotrexate | Methotrexate |
| 63323-122 | Methotrexate | Methotrexate |
| 63323-123 | Methotrexate | Methotrexate |
| 66336-338 | METHOTREXATE | METHOTREXATE |
| 67253-320 | METHOTREXATE | METHOTREXATE |
| 67457-480 | Methotrexate | Methotrexate |
| 67457-466 | Methotrexate | Methotrexate |
| 71335-1118 | Methotrexate | Methotrexate |