LORAZEPAM
- Product NDC
- 13107-085
- 11-digit product format
- 131070085
- Labeler code
- 13107
- Product ID
- 13107-085_67012944-0947-4e64-adab-869993f2f709
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LORAZEPAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA203572
- Marketing category
- ANDA
- Marketing start
- 2021-02-01
- Substance
- LORAZEPAM
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O26FZP769L |
| Rxcui | 197900, 197901, 197902 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-085-01 | LORAZEPAM | 100 in 1 BOTTLE | TABLET | 100 | | 9 |
| 13107-085-05 | LORAZEPAM | 500 in 1 BOTTLE | TABLET | 500 | | 9 |
| 13107-085-10 | LORAZEPAM | 10 in 1 BOTTLE | TABLET | 10 | | 9 |
| 13107-085-99 | LORAZEPAM | 1000 in 1 BOTTLE | TABLET | 1000 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-085 | LORAZEPAM TABLET [AUROLIFE PHARMA LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240821_5b851f67-309d-4ef3-8b4b-ade8908256ea.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 |
|---|
| 13107-085-01 | 13107008501 | 100 TABLET in 1 BOTTLE (13107-085-01) | 100 tablet | 2021-02-01 | 0000-00-00 | No | No | Current |
| 13107-085-05 | 13107008505 | 500 TABLET in 1 BOTTLE (13107-085-05) | 500 tablet | 2021-02-01 | 0000-00-00 | No | No | Current |
| 13107-085-10 | 13107008510 | 10 TABLET in 1 BOTTLE (13107-085-10) | 10 tablet | 2021-02-01 | 0000-00-00 | No | No | Current |
| 13107-085-11 | 13107008511 | 10 TABLET in 1 BOTTLE (13107-085-11) | 10 tablet | 2017-03-24 | 0000-00-00 | No | No | Current |
| 13107-085-99 | 13107008599 | 1000 TABLET in 1 BOTTLE (13107-085-99) | 1000 tablet | 2021-02-01 | 0000-00-00 | No | No | Current |