Midazolam Hydrochloride
- Product NDC
- 68094-764
- 11-digit product format
- 680940764
- Labeler code
- 68094
- Product ID
- 68094-764_2224d61f-f386-40dc-ba55-a7cf7b66358f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Midazolam Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Precision Dose Inc.
- Application
- ANDA075873
- Marketing category
- ANDA
- Marketing start
- 2015-05-26
- Substance
- MIDAZOLAM HYDROCHLORIDE
- Active strength
- 2 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Midazolam Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIDAZOLAM HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W7TTW573JJ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68094-764-59 | Midazolam Hydrochloride | 5 mL in 1 CUP, UNIT-DOSE | SYRUP | 5 | | 5 |
| 68094-764-62 | Midazolam Hydrochloride | 10 in 1 TRAY | SYRUP | 10 | | 5 |
| 68094-764-62 | Midazolam Hydrochloride | 3 in 1 CASE | SYRUP | 3 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68094-764 | MIDAZOLAM HYDROCHLORIDE SYRUP [PRECISION DOSE INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20231230_9a443652-6aff-4e27-83fe-90c65fa0f3c1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68094-764-59 | 68094076459 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 68094-764-62 | 68094076462 | 3 TRAY in 1 CASE (68094-764-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-764-59) | 3 tray | 2015-05-26 | 0000-00-00 | No | No | Current |