N/A
- Product NDC
- 71053-595
- 11-digit product format
- 710530595
- Labeler code
- 71053
- Product ID
- 71053-595_4b1cba4c-3cc1-5642-e063-6294a90a4522
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam Injection, 10 mg
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Rafa Laboratories, Ltd.
- Application
- NDA216359
- Marketing category
- NDA
- Marketing start
- 2022-08-08
- Substance
- MIDAZOLAM
- Active strength
- 10 mg/.7mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM | 10 mg/.7mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R60L0SM5BC |
| Rxcui | 2608698 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 71053-595-01 | 2024-05-06 | C162847 | 48780-1 | 0191ceaa-6798-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985 |
| 71053-595-01 | 2024-01-30 | C162847 | 48780-1 | 0191ceaa-6798-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985 |
| 71053-595-01 | 2023-10-31 | C162847 | 48780-1 | 0191ceaa-6798-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985 |
| 71053-595-01 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6798-198a-e063-dbdaa90aec3e | These highlights do not include all the information needed to use MIDAZOLAM INJECTION safely and effectively. See full prescribing information for MIDAZOLAM INJECTION. MIDAZOLAM injection, for intramuscular use, CIV Initial U.S. Approval: 1985 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71053-595-01 | N/A | 40 in 1 CARTON | INJECTION, SOLUTION | 40 | | 5 |
| 71053-595-01 | N/A | 480 in 1 BOX | INJECTION, SOLUTION | 480 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71053-595 | N/A (MIDAZOLAM INJECTION, 10 MG) INJECTION, SOLUTION [RAFA LABORATORIES, LTD.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240510_d7362b4d-68a3-99a0-e053-2995a90a4f60.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71053-595-01 | 71053059501 | 480 CARTON in 1 BOX (71053-595-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE | 480 carton | 2022-08-08 | 0000-00-00 | No | No | Current |