Lorazepam
- Product NDC
- 0641-6044
- 11-digit product format
- 006416044
- Labeler code
- 0641
- Product ID
- 0641-6044_7c73dbc6-2623-4443-9b05-97dec7a0be2e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA018140
- Marketing category
- NDA
- Marketing start
- 1980-07-25
- Substance
- LORAZEPAM
- 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
- Lorazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORAZEPAM | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O26FZP769L |
| Rxcui | 238100, 238101, 1665188, 1665326 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6044-01 | Lorazepam | 1 mL in 1 VIAL | INJECTION | 1 | | 10 |
| 0641-6044-25 | Lorazepam | 25 in 1 CARTON | INJECTION | 25 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6044 | LORAZEPAM INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240410_e9b54e42-04cf-4c62-90e1-36f7b31a4e81.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 |
|---|
| 0641-6044-01 | 00641604401 | 1 mL in 1 VIAL | 1 ml | | | | | Historical |
| 0641-6044-25 | 00641604425 | 25 VIAL in 1 CARTON (0641-6044-25) / 1 mL in 1 VIAL (0641-6044-01) | 25 vial | 1980-07-25 | 0000-00-00 | No | No | Current |