Lorazepam
- Product NDC
- 65219-368
- 11-digit product format
- 652190368
- Labeler code
- 65219
- Product ID
- 65219-368_462a13da-259a-40e7-bd5b-f7f42ae025b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA217598
- Marketing category
- ANDA
- Marketing start
- 2024-12-13
- Substance
- LORAZEPAM
- Active strength
- 2 mg/mL
- 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
- Brand name base
- Lorazepam
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LORAZEPAM | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O26FZP769L |
| Rxcui | 1665188 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-368-01 | Lorazepam | 1 mL in 1 VIAL | INJECTION | 1 | | 1 |
| 65219-368-02 | Lorazepam | 25 in 1 TRAY | INJECTION | 25 | | 1 |
| 65219-368-14 | Lorazepam | 1 mL in 1 VIAL | INJECTION | 1 | | 1 |
| 65219-368-24 | Lorazepam | 25 in 1 TRAY | INJECTION | 25 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-368 | LORAZEPAM INJECTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20241213_b2487467-a63f-48b5-b0de-3a6ce6672d50.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-368-01 | 65219036801 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 65219-368-02 | 65219036802 | 25 VIAL in 1 TRAY (65219-368-02) / 1 mL in 1 VIAL (65219-368-01) | 25 vial | 2024-12-13 | No | No | Current |
| 65219-368-14 | 65219036814 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 65219-368-24 | 65219036824 | 25 VIAL in 1 TRAY (65219-368-24) / 1 mL in 1 VIAL (65219-368-14) | 25 vial | 2024-12-13 | No | No | Current |