Methotrexate
- Product NDC
- 61703-124
- 11-digit product format
- 617030124
- Labeler code
- 61703
- Product ID
- 61703-124_6bb8643f-6ab4-4e1c-bcf9-b82e8cf18910
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- NDA011719
- Marketing category
- NDA
- Marketing start
- 2022-10-17
- Substance
- METHOTREXATE SODIUM
- Active strength
- 25 mg/mL
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011719-001 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011719-003 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011719-004 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011719-005 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011719-006 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N011719-007 | METHOTREXATE LPF | METHOTREXATE SODIUM | EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-03-31 | |
| N011719-009 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1988-04-07 | |
| N011719-010 | METHOTREXATE SODIUM | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2004-12-15 |
| N011719-011 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | |
| N011719-012 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2005-04-13 |
| N011719-013 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | |
| N011719-014 | METHOTREXATE PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011719-010 | AP |
| N011719-012 | AP |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N011719-001 | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011719-003 | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011719-004 | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011719-005 | METHOTREXATE SODIUM | EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011719-006 | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011719-007 | METHOTREXATE LPF | EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1982-03-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011719-009 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1988-04-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011719-010 | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2004-12-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011719-011 | METHOTREXATE PRESERVATIVE FREE | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011719-012 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2005-04-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011719-013 | METHOTREXATE PRESERVATIVE FREE | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011719-014 | METHOTREXATE PRESERVATIVE FREE | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-001 | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011719-003 | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011719-004 | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011719-005 | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011719-006 | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011719-007 | METHOTREXATE LPF | EQ 25MG BASE/ML | INJECTABLE / INJECTION | RLD | 1982-03-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-009 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD | 1988-04-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-010 | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2004-12-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-011 | METHOTREXATE PRESERVATIVE FREE | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2005-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-012 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2005-04-13 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-013 | METHOTREXATE PRESERVATIVE FREE | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-014 | METHOTREXATE PRESERVATIVE FREE | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2005-04-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-001 | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-003 | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-004 | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-005 | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-006 | METHOTREXATE SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-007 | METHOTREXATE LPF | EQ 25MG BASE/ML | INJECTABLE / INJECTION | RLD | 1982-03-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-009 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | RLD | 1988-04-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-010 | METHOTREXATE SODIUM | EQ 50MG BASE/2ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2004-12-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-011 | METHOTREXATE PRESERVATIVE FREE | EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2005-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-012 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RLD, RS | 2005-04-13 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-013 | METHOTREXATE PRESERVATIVE FREE | EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 2005-04-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-014 | METHOTREXATE PRESERVATIVE FREE | EQ 20MG BASE/2ML (EQ 10MG BASE/ML) | INJECTABLE / INJECTION | RLD | 2005-04-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011719-001 | METHOTREXATE SODIUM | EQ 20MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011719-003 | METHOTREXATE SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011719-004 | METHOTREXATE SODIUM | EQ 2.5MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011719-005 | METHOTREXATE SODIUM | EQ 25MG BASE/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N011719-010 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011719-012 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-010 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011719-012 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-010 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011719-012 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011719-010 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N011719-012 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011719-010 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011719-012 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011719-010 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011719-012 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011719-010 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011719-012 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011719-010 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011719-012 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011719-010 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011719-012 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011719-010 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011719-012 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011719-010 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N011719-012 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011719-010 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011719-012 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011719-010 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011719-012 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011719-010 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011719-012 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N011719-010 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N011719-012 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011719-010 | AP | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N011719-012 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N011719-010 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N011719-012 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N011719-010 | AP | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N011719-012 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N011719-010 | AP | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N011719-012 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N011719-010 | AP | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N011719-012 | AP | 1 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methotrexate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHOTREXATE SODIUM | 25 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3IG1E710ZN | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bd287e89-32f9-4396-95fa-4b562869f476 | Available on FDA.report |
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 |
|---|---|---|---|---|---|---|
| 61703-124-40 | Methotrexate | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 6 | |
| 61703-124-40 | Methotrexate | 40 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 40 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61703-124-40 | ML - Milliliter | 61703-124 | c3711fd3-65d0-4dad-a422-8d16b3901301 | 1 | 2023-02-06 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methotrexate | METHOTREXATE | Hospira, Inc. | 0e30eaef-5a09-4104-8a11-c32933eadeab | 2025-08-22 | Boxed warning, Warnings, Adverse reactions | 011719 NDA011719 |
| Methotrexate | METHOTREXATE | Hospira, Inc. | bd287e89-32f9-4396-95fa-4b562869f476 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | 011719 NDA011719 61703-124 |
| Methotrexate | METHOTREXATE | Hospira, Inc. | 0d63ba29-b692-41b4-87e8-351265c8273f | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | 011719 NDA011719 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1655956 | methotrexate 1 GM in 40 ML Injection | PSN | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
| 1946772 | methotrexate 25 MG/mL Injectable Solution | PSN | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
| 1655956 | 40 ML methotrexate 25 MG/ML Injection | SCD | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
| 1946772 | methotrexate 25 MG/ML Injectable Solution | SCD | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
| 1946772 | methotrexate (as methotrexate sodium) 25 MG/ML Injectable Solution | SY | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
| 1655956 | methotrexate 1 GM per 40 ML Injection | SY | bd287e89-32f9-4396-95fa-4b562869f476 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61703-124-40 | 61703012440 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-124-40) / 40 mL in 1 VIAL, SINGLE-DOSE | 2022-10-17 | 0000-00-00 | No | No | Current |