METHOTREXATE
- Product NDC
- 55150-513
- 11-digit product format
- 551500513
- Labeler code
- 55150
- Product ID
- 55150-513_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHOTREXATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA201529
- Marketing category
- ANDA
- Marketing start
- 2024-09-11
- Substance
- METHOTREXATE SODIUM
- Active strength
- 250 mg/10mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 2eb9a854-4fbc-9bbe-3199-41fc1018a1f0 | Product name | 9 | 20250224 |
| 3082de91-569a-4d57-b379-acbf37f1d5c3 | Product name | 1 | 20210312 |
| f76135bc-a210-42d9-851b-1b73cbaccdb3 | Product name | 1 | 20200511 |
| 423544b2-e325-49ee-8910-4c5dfe41906f | Product name | 1 | 20181120 |
| c9fd924b-0a8d-4d53-bf70-11070e24e4dd | Product name | 2 | 20181120 |
| ce1e7cc6-4850-4cb1-8dde-8010b2fbc359 | Product name | 1 | 20181120 |
| eb454f54-2806-4c31-a08b-8dcb08261099 | Product name | 2 | 20181120 |
| d9cebc09-c68d-46f5-bdcd-fd82e945cc27 | Product name | 1 | 20170705 |
| 16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3 | Product name | 2 | 20160504 |
| 88514aea-9d58-4ed2-b135-9811fb14c8fb | Product name | 1 | 20141209 |
| 0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55150-513-01 | METHOTREXATE | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | 2 | |
| 55150-513-01 | METHOTREXATE | 01 in 1 CARTON | INJECTION, SOLUTION | 01 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1655967 | methotrexate 100 MG in 4 ML Injection | PSN | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655968 | methotrexate 200 MG in 8 ML Injection | PSN | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655959 | methotrexate 250 MG in 10 ML Injection | PSN | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655960 | methotrexate 50 MG in 2 ML Injection | PSN | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655959 | 10 ML methotrexate 25 MG/ML Injection | SCD | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655960 | 2 ML methotrexate 25 MG/ML Injection | SCD | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655967 | 4 ML methotrexate 25 MG/ML Injection | SCD | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655968 | 8 ML methotrexate 25 MG/ML Injection | SCD | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655967 | methotrexate 100 MG per 4 ML Injection | SY | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655968 | methotrexate 200 MG per 8 ML Injection | SY | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655959 | methotrexate 250 MG per 10 ML Injection | SY | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
| 1655960 | methotrexate 50 MG per 2 ML Injection | SY | 63bb6fbf-dd59-4edc-af8f-d0c397ca1262 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55150-513-01 | 55150051301 | 1 VIAL in 1 CARTON (55150-513-01) / 10 mL in 1 VIAL | 1 vial | 2024-09-11 | No | No | Historical |