Lorazepam
- Product NDC
- 0054-3532
- 11-digit product format
- 000543532
- Labeler code
- 0054
- Product ID
- 0054-3532_a0e90170-76ad-4493-991c-551903b42b09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA072755
- Marketing category
- ANDA
- Marketing start
- 1991-06-28
- 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 | 311376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-3532-44 | Lorazepam | 30 mL in 1 BOTTLE | SOLUTION, CONCENTRATE | 30 | | 12 |
| 0054-3532-44 | Lorazepam | 1 in 1 CARTON | SOLUTION, CONCENTRATE | 1 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LORAZEPAM | ACTIVE INGREDIENT | O26FZP769L | LORAZEPAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 5 | |
| LORAZEPAM | ACTIVE MOIETY | O26FZP769L | LORAZEPAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | LORAZEPAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LORAZEPAM SOLUTION, CONCENTRATE [ROXANE LABORATORIES, INC] | 5 | |
| LORAZEPAM | ACTIVE INGREDIENT | O26FZP769L | LORAZEPAM SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| LORAZEPAM | ACTIVE MOIETY | O26FZP769L | LORAZEPAM SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | LORAZEPAM SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LORAZEPAM SOLUTION, CONCENTRATE [PHYSICIANS TOTAL CARE, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0054-3532 | LORAZEPAM SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 12 | Current NDC, Legacy NDC, 2 package rows | 20231202_5ff82103-cc57-4af9-9362-82a7c686271d.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 |
|---|
| 0054-3532-44 | 00054353244 | 1 BOTTLE in 1 CARTON (0054-3532-44) / 30 mL in 1 BOTTLE | 1 bottle | 1991-06-28 | 0000-00-00 | No | No | Current |