Application 211844
- Type
- NDA
- Sponsor
- INFORLIFE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM | MIDAZOLAM | UNKNOWN | UNKNOWN | Yes | No |
| 002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | SOLUTION;INTRAVENOUS | 100MG/100ML (1MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 |
| N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N211844-001 | AP |
| N211844-002 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | |
| N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 |
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 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | RLD, RS | 2021-03-22 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211844-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211844-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2021-03-22 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N211844-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N211844-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N211844-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N211844-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211844-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211844-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N211844-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N211844-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N211844-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N211844-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211844-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211844-002 | AP | 1 | a72a2bbeb626… |
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 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211844-001 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211844-002 | 10966990 | 2038-06-20 | Drug product | 2021-04-16 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Midazolam | MIDAZOLAM HYDROCHLORIDE | REMEDYREPACK INC. | d9305142-417d-4d8c-9a23-f9a1b6771cac | 2026-09-04 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| MIDAZOLAM | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | b95415fa-17c2-42ab-a6b0-e628d01c94ed | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | MIDAZOLAM |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Onesource Specialty Pharma Limited | a0e9a149-7a4c-4f66-91af-91695ee2e40c | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | 1abda8b8-48a8-4995-af86-39220d1aa240 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Onesource Specialty Pharma Limited | 54ed43b2-bad1-4b45-e063-6294a90a793a | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM | Civica, Inc. | f0c8b6cd-9efc-4344-9212-fbdd3b8e2f9b | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Cardinal Health 107, LLC | cbedf0bf-82a4-4214-96d5-01ac35e101f0 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Hospira, Inc. | affecd4d-1f78-4bbe-5a8d-86849bbdc520 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM | Henry Schein, Inc. | 3c2fd6ee-4ede-4ee4-8c05-34c93598f381 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Henry Schein, Inc. | 78e28b13-414e-4c34-a42c-caf1c3ba1f54 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Henry Schein, Inc. | 90f7b7f6-d0fd-40af-bbfa-70b152e3e27c | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Henry Schein, Inc. | 94e1342b-f597-44c0-b8fc-b753fde04cbe | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | f8bb3427-c887-47b6-8042-8a21dc161c79 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | a91ce254-14a3-4cbf-8ab8-5da252aa3fdc | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 8675cdb1-c7f5-40cf-b1e0-0960b7ab117b | 2024-04-10 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 575d8bf0-7af7-427c-a231-966e2a5e070d | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM | Hikma Pharmaceuticals USA Inc. | 51c8bfa4-5c78-4b7a-9ffb-8f00828acadc | 2024-03-29 | Boxed warning, Warnings, Adverse reactions | Midazolam MIDAZOLAM |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Fresenius Kabi USA, LLC | 1cc9ba6e-fa1b-405e-9de8-720c567b2a73 | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | Steriscience Specialties Private Limited | 473fba4b-8754-4b1d-bba9-d9c8f6d818e0 | 2023-12-13 | Boxed warning, Warnings, Adverse reactions | Midazolam |
| Midazolam | MIDAZOLAM HYDROCHLORIDE | SOMERSET THERAPEUTICS, LLC | 74666098-1ca8-4c06-8fc4-5de870b1b514 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | Midazolam |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 44567-610 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-610 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-610 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-610 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-610 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-611 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-611 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-611 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-611 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |
| 44567-611 | MIDAZOLAM HYDROCHLORIDE | MIDAZOLAM HYDROCHLORIDE | WG Critical Care, LLC. | NDA | Current |