Lorazepam
- Product NDC
- 63304-774
- 11-digit product format
- 633040774
- Labeler code
- 63304
- Product ID
- 63304-774_b8fbb599-96d9-4866-908d-d8be424e5ee3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- SUN PHARMACEUTICAL INDUSTRIES INC
- Application
- ANDA076045
- Marketing category
- ANDA
- Marketing start
- 2023-06-25
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63304-774-01 | 2023-07-06 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-05 | 2023-07-06 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-10 | 2023-07-06 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-30 | 2023-07-06 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-90 | 2023-07-06 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-05 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
| 63304-774-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-c031-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-774-01 | Lorazepam | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 63304-774-05 | Lorazepam | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
| 63304-774-10 | Lorazepam | 1000 in 1 BOTTLE | TABLET | 1000 | | 4 |
| 63304-774-90 | Lorazepam | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-774 | LORAZEPAM TABLET [SUN PHARMACEUTICAL INDUSTRIES INC] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230707_0c1caa9c-9ef1-459c-86c3-adb939130a9f.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 |
|---|
| 63304-774-01 | 63304077401 | 100 TABLET in 1 BOTTLE (63304-774-01) | 100 tablet | 2023-06-25 | No | No | Current |
| 63304-774-05 | 63304077405 | 500 TABLET in 1 BOTTLE (63304-774-05) | 500 tablet | 2023-06-25 | No | No | Current |
| 63304-774-10 | 63304077410 | 1000 TABLET in 1 BOTTLE (63304-774-10) | 1000 tablet | 2023-06-25 | No | No | Current |
| 63304-774-90 | 63304077490 | 90 TABLET in 1 BOTTLE (63304-774-90) | 90 tablet | 2023-06-25 | No | No | Current |