Midazolam in Sodium Chloride
- Product NDC
- 0143-9380
- 11-digit product format
- 001439380
- Labeler code
- 0143
- Product ID
- 0143-9380_a6be32fe-dc3d-4ce0-b780-8ba6b4261acc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam in Sodium Chloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA216159
- Marketing category
- ANDA
- Marketing start
- 2023-05-19
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- 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 |
|---|---|---|---|---|---|---|---|
| A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | |
| A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | MIDAZOLAM | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216159-001 | AP |
| A216159-002 | 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 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-001 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 50MG/50ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-002 | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | 100MG/100ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2023-04-17 | 9b2671bbb829… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216159-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A216159-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216159-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216159-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216159-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216159-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216159-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216159-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216159-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216159-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216159-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216159-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-002 | AP | 1 | 9b2671bbb829… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-001 | PC | 2024-01-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216159-002 | PC | 2024-01-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-001 | PC | 2024-01-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216159-002 | PC | 2024-01-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-001 | PC | 2024-01-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216159-002 | PC | 2024-01-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-001 | PC | 2024-01-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216159-002 | PC | 2024-01-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-001 | PC | 2024-01-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216159-002 | PC | 2024-01-02 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-001 | PC | 2024-01-02 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216159-002 | PC | 2024-01-02 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-001 | PC | 2024-01-02 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216159-002 | PC | 2024-01-02 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-001 | PC | 2024-01-02 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216159-002 | PC | 2024-01-02 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-001 | PC | 2024-01-02 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A216159-002 | PC | 2024-01-02 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-001 | PC | 2024-01-02 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216159-002 | PC | 2024-01-02 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-001 | PC | 2024-01-02 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A216159-002 | PC | 2024-01-02 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-001 | PC | 2024-01-02 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A216159-002 | PC | 2024-01-02 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-001 | PC | 2024-01-02 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216159-002 | PC | 2024-01-02 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-001 | PC | 2024-01-02 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216159-002 | PC | 2024-01-02 | 9b2671bbb829… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam in Sodium Chloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MIDAZOLAM HYDROCHLORIDE | 1 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| W7TTW573JJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1d526338-43ba-4cef-8730-5a757122f8ce | Product name | 1 | 20260218 |
| 8118475d-d61b-4326-b353-56e9cf8c8d9f | Product name | 3 | 20260218 |
| f69f3735-bf62-03e6-cc7a-5af4af89ec8a | Product name | 5 | 20250516 |
| 4cc03496-da49-494d-b71d-757fe6737fa2 | Product name | 1 | 20230717 |
| 06641162-4d53-492d-8ff2-5951a469060f | Product name | 1 | 20230420 |
| 46ca420c-e4d5-4e6c-9b2f-cea269a262e8 | Product name | 1 | 20230320 |
| b84efe2b-3f4e-4b09-90f9-1d24a61ec30e | Product name | 1 | 20190808 |
| bb7f99f4-8b2b-42a4-8f5a-fcf7dc204f16 | Product name | 1 | 20181220 |
| 31f18c4e-1938-700a-43de-b9e218c36edc | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0143-9380-01 | Midazolam in Sodium Chloride | 100 mL in 1 BAG | INJECTION | 100 | 2 | |
| 0143-9380-01 | Midazolam in Sodium Chloride | 1 in 1 POUCH | INJECTION | 1 | 2 | |
| 0143-9380-10 | Midazolam in Sodium Chloride | 10 in 1 CARTON | INJECTION | 10 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0143-9380-01 | ML - Milliliter | 0143-9380 | b8c1d304-7cb3-424f-8e75-7ef6724708ad | 1 | 2023-07-06 |
| 0143-9380-10 | ML - Milliliter | 0143-9380 | 3de5cd8c-58f7-47bc-b761-3ca4c320c946 | 1 | 2023-07-06 |
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 |
|---|---|---|---|---|---|---|
| Midazolam in Sodium Chloride | MIDAZOLAM IN SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2023-02-07 | Boxed warning, Warnings, Adverse reactions | 216159 ANDA216159 0143-9380 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2541171 | midazolam 100 MG in 100 mL Injection | PSN | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
| 2541170 | midazolam 50 MG in 50 mL Injection | PSN | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
| 2541171 | 100 ML midazolam 1 MG/ML Injection | SCD | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
| 2541170 | 50 ML midazolam 1 MG/ML Injection | SCD | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
| 2541171 | midazolam 100 MG per 100 ML Injection | SY | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
| 2541170 | midazolam 50 MG per 50 ML Injection | SY | 4155a60a-b023-4f4a-acae-7bb8fe9dc0c1 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0143-9380-01 | 00143938001 | 100 mL in 1 BAG | 100 ml | Historical | |||
| 0143-9380-10 | 00143938010 | 10 POUCH in 1 CARTON (0143-9380-10) / 1 BAG in 1 POUCH (0143-9380-01) / 100 mL in 1 BAG | 10 pouch | 2023-05-19 | No | No | Current |