Lorazepam
- Product NDC
- 54348-049
- 11-digit product format
- 543480049
- Labeler code
- 54348
- Product ID
- 54348-049_43401437-96cf-aa9c-e063-6394a90aedd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LORAZEPAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA078203
- Marketing category
- ANDA
- Marketing start
- 2019-07-11
- Substance
- LORAZEPAM
- Active strength
- 1 mg/1
- 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O26FZP769L |
| Rxcui | 197901 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54348-049-01 | Lorazepam | 1 in 1 BOTTLE | TABLET | 1 | | 3 |
| 54348-049-01 | Lorazepam | 1 in 1 BOX | TABLET | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-049 | LORAZEPAM TABLET [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221011_b6e4d2c7-10c0-4d77-be7b-caa3d3b86997.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 |
|---|
| 54348-049-01 | 54348004901 | 1 BOTTLE in 1 BOX (54348-049-01) / 1 TABLET in 1 BOTTLE | 1 bottle | 2019-07-11 | 0000-00-00 | No | No | Current |