Monoferric
- Product NDC
- 49442-9301
- 11-digit product format
- 494429301
- Labeler code
- 49442
- Product ID
- 49442-9301_93bb10c4-9862-4eda-927f-206ab5c2f7f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ferric derisomaltose
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pharmacosmos A/S
- Application
- NDA208171
- Marketing category
- NDA
- Marketing start
- 2020-01-16
- Marketing end
- 0000-00-00
- Substance
- FERRIC DERISOMALTOSE
- Active strength
- 100 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49442-9301 | D | Discontinued by firm | 2026-10-12 | ||
| excluded package | package | 49442-9301 | 49442-9301-2 | D | Discontinued by firm | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49442-9301-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49442-9301-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49442-9301-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49442-9301-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49442-9301-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49442-9301-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49442-9301-2 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49442-9301-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49442-9301-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49442-9301-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 49442-9301-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 49442-9301-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208171-001 | MONOFERRIC | FERRIC DERISOMALTOSE | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | |
| N208171-002 | MONOFERRIC | FERRIC DERISOMALTOSE | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | |
| N208171-003 | MONOFERRIC | FERRIC DERISOMALTOSE | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208171-001 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | |
| N208171-001 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | |
| N208171-001 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | |
| N208171-001 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 |
| N208171-001 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | |
| N208171-002 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | |
| N208171-002 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | |
| N208171-002 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | |
| N208171-002 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 |
| N208171-002 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | |
| N208171-003 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | |
| N208171-003 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | |
| N208171-003 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | |
| N208171-003 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 |
| N208171-003 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208171-002 | MONOFERRIC | 500MG/5ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208171-003 | MONOFERRIC | 1GM/10ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2020-01-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208171-001 | MONOFERRIC | 100MG/ML (100MG/ML) | SOLUTION / INTRAVENOUS | RLD | 2020-01-16 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208171-001 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208171-002 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208171-003 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208171-001 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208171-002 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208171-003 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-001 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | 10414831 | 2029-03-25 | Drug substance, Drug product | 2020-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | 11851504 | 2029-03-25 | Drug substance, Drug product | 2024-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | 12030962 | 2029-03-25 | Drug substance, Drug product | 2024-08-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | 8815301 | 2029-08-14 | U-2734 | Drug substance, Drug product | 2020-02-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N208171-002 | 11633489 | 2036-06-22 | U-3594 | 2023-05-24 | 011fe1cb6892… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| Monoferric | FERRIC DERISOMALTOSE | Pharmacosmos Therapeutics Inc. | 55859d2d-0456-4fa9-b41f-f535accc97db | 2025-11-25 | Warnings, Adverse reactions | 208171 NDA208171 |