Midazolam Hydrochloride
- Product NDC
- 68258-8981
- 11-digit product format
- 682588981
- Labeler code
- 68258
- Product ID
- 68258-8981_b5c3b5fc-3d14-4da6-8b9e-dc04ba5cab51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIDAZOLAM HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Dispensing Solutions, Inc.
- Application
- ANDA075293
- Marketing category
- ANDA
- Marketing start
- 2011-05-03
- Marketing end
- 0000-00-00
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68258-8981-1 | Midazolam Hydrochloride | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 2 |
| 68258-8981-1 | Midazolam Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIDAZOLAM HYDROCHLORIDE | ACTIVE INGREDIENT | W7TTW573JJ | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| MIDAZOLAM | ACTIVE MOIETY | R60L0SM5BC | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68258-8981 | MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS, INC.] | 2 | Legacy NDC, 2 package rows | 20120216_249af7c9-8e3a-4fae-aa78-46bbeab44fe1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68258-8981-1 | 68258898101 | 10 mL in 1 VIAL | 10 ml | Historical |