Midazolam
- Product NDC
- 47781-589
- 11-digit product format
- 477810589
- Labeler code
- 47781
- Product ID
- 47781-589_6ecc698c-b49e-cddf-0ce3-8b8e1391aab6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- midazolam hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Alvogen Inc.
- Application
- ANDA090850
- Marketing category
- ANDA
- Marketing start
- 2017-08-11
- Marketing end
- 2023-06-01
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
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 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 47781-589-17 | ML - Milliliter | 47781-589 | a365d865-6a12-4f72-a3d9-674f38f2682f | 1 | 2017-09-11 |
| 47781-589-20 | ML - Milliliter | 47781-589 | d89619a8-5348-49fb-aa97-beccf7482e14 | 1 | 2017-10-13 |
| 47781-589-22 | ML - Milliliter | 47781-589 | 050642c1-3eb4-44f9-9e1e-017a081ed8d4 | 1 | 2017-10-13 |
| 47781-589-91 | ML - Milliliter | 47781-589 | 40974911-4618-49cb-9a8b-7a63087f0cf0 | 1 | 2017-09-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311702 | midazolam 5 MG/ML Injectable Solution | PSN | 3060c8c6-7de2-45af-84fc-2ea37d0de071 | 2 |
| 311702 | midazolam 5 MG/ML Injectable Solution | SCD | 3060c8c6-7de2-45af-84fc-2ea37d0de071 | 2 |
| 311702 | midazolam (as midazolam hydrochloride) 5 MG/ML Injectable Solution | SY | 3060c8c6-7de2-45af-84fc-2ea37d0de071 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 47781-589-91 | 47781058991 | 10 VIAL, MULTI-DOSE in 1 CARTON (47781-589-91) > 10 mL in 1 VIAL, MULTI-DOSE (47781-589-22) | 2017-08-11 | 2023-06-01 | No | No | Current |