Methotrexate
- Product NDC
- 48433-065
- 11-digit product format
- 484330065
- Labeler code
- 48433
- Product ID
- 48433-065_49a1fdee-5587-e05a-e063-6294a90aebc5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methotrexate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA081235
- Marketing category
- ANDA
- Marketing start
- 2026-01-19
- Substance
- METHOTREXATE SODIUM
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|---|
| 48433-065-01 | Methotrexate | 1 in 1 BLISTER PACK | TABLET | 1 | 2 | |
| 48433-065-05 | Methotrexate | 20 in 1 CARTON | TABLET | 20 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 48433-065-05 | EA - Each | 48433-065 | 9323610b-703d-4b26-aa83-8eaef0922050 | 1 | 2026-05-22 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 105585 | methotrexate 2.5 MG Oral Tablet | PSN | f177e6fa-c482-432d-8208-937468ab3f10 | 2 |
| 105585 | methotrexate 2.5 MG Oral Tablet | SCD | f177e6fa-c482-432d-8208-937468ab3f10 | 2 |
| 105585 | methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet | SY | f177e6fa-c482-432d-8208-937468ab3f10 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 48433-065-01 | 48433006501 | 1 in 1 BLISTER PACK | Historical | ||||
| 48433-065-05 | 48433006505 | 20 BLISTER PACK in 1 CARTON (48433-065-05) / 1 TABLET in 1 BLISTER PACK (48433-065-01) | 20 blister pack | 2026-01-19 | No | No | Historical |