Methotrexate
- Product NDC
- 16729-277
- 11-digit product format
- 167290277
- Labeler code
- 16729
- Product ID
- 16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methotrexate
- Dosage form
- INJECTION
- Route
- INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA040716
- Marketing category
- ANDA
- Marketing start
- 2014-03-07
- Substance
- METHOTREXATE
- 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 |
|---|---|---|---|---|---|---|---|
| A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | METHOTREXATE SODIUM | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040716-001 | 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 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040716-001 | METHOTREXATE SODIUM PRESERVATIVE FREE | EQ 1GM BASE/40ML (EQ 25MG BASE/ML) | INJECTABLE / INJECTION | AP | RS | 2007-04-30 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040716-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040716-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040716-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040716-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040716-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040716-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040716-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040716-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040716-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040716-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040716-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040716-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040716-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040716-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040716-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040716-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040716-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040716-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040716-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040716-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040716-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040716-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040716-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040716-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040716-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040716-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040716-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040716-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040716-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040716-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040716-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040716-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040716-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040716-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040716-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040716-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040716-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040716-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040716-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040716-001 | AP | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Methotrexate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| METHOTREXATE | 25 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| YL5FZ2Y5U1 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 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 |
|---|---|---|---|---|---|---|
| 16729-277-03 | Methotrexate | 1 in 1 CARTON | INJECTION | 1 | 6 | |
| 16729-277-03 | Methotrexate | 10 mL in 1 VIAL | INJECTION | 10 | 6 | |
| 16729-277-30 | Methotrexate | 1 in 1 CARTON | INJECTION | 1 | 6 | |
| 16729-277-30 | Methotrexate | 2 mL in 1 VIAL | INJECTION | 2 | 6 | |
| 16729-277-35 | Methotrexate | 40 mL in 1 VIAL | INJECTION | 40 | 6 | |
| 16729-277-35 | Methotrexate | 1 in 1 CARTON | INJECTION | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-277-03 | ML - Milliliter | 16729-277 | d5410565-7b82-4c8e-84ea-9bd78573206a | 1 | 2014-04-03 |
| 16729-277-30 | ML - Milliliter | 16729-277 | 7f4ded3d-08d1-45af-ac05-def9c248147a | 1 | 2014-04-03 |
| 16729-277-35 | ML - Milliliter | 16729-277 | 80486de1-b61e-4b26-90fd-ebf539e41583 | 1 | 2014-04-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| METHOTREXATE | ACTIVE INGREDIENT | YL5FZ2Y5U1 | METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] | 1 | |
| METHOTREXATE | ACTIVE MOIETY | YL5FZ2Y5U1 | METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.] | 1 |
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 | Accord Healthcare, Inc. | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 040716 ANDA040716 16729-277 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1655956 | methotrexate 1 GM in 40 ML Injection | PSN | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655959 | methotrexate 250 MG in 10 ML Injection | PSN | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655960 | methotrexate 50 MG in 2 ML Injection | PSN | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655959 | 10 ML methotrexate 25 MG/ML Injection | SCD | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655960 | 2 ML methotrexate 25 MG/ML Injection | SCD | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655956 | 40 ML methotrexate 25 MG/ML Injection | SCD | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655956 | methotrexate 1 GM per 40 ML Injection | SY | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655959 | methotrexate 250 MG per 10 ML Injection | SY | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
| 1655960 | methotrexate 50 MG per 2 ML Injection | SY | dd035a9f-cd40-4314-b9d8-2294b8a924e2 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16729-277-03 | 16729027703 | 1 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL | 1 vial | 2014-03-07 | 0000-00-00 | No | No | Current |
| 16729-277-30 | 16729027730 | 1 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL | 1 vial | 2014-03-07 | 0000-00-00 | No | No | Current |
| 16729-277-35 | 16729027735 | 1 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL | 1 vial | 2014-03-07 | 0000-00-00 | No | No | Current |