Lorazepam
- Product NDC
- 53217-216
- 11-digit product format
- 532170216
- Labeler code
- 53217
- Product ID
- 53217-216_cf46170b-7873-4a42-bdc2-292e1861b5be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA078203
- Marketing category
- ANDA
- Marketing start
- 2007-10-01
- Marketing end
- 0000-00-00
- Substance
- LORAZEPAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a759f740-8682-4896-9194-8b6c103c9aee | Product name | 3 | 20250716 |
| b7badb1c-6d3f-4f95-a4ca-ce69992e58a1 | Product name | 1 | 20220308 |
| 5d98a0ba-a64b-d9b2-e6ec-87edbb57a285 | Product name | 2 | 20180320 |
| ac8efea8-f412-295f-00ce-b095e5cbc115 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-216-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6193-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
| 53217-216-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6193-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
| 53217-216-45 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6193-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
| 53217-216-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6193-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
| 53217-216-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-6193-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-216-15 | Lorazepam | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 53217-216-30 | Lorazepam | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 53217-216-45 | Lorazepam | 45 in 1 BOTTLE | TABLET | 45 | 1 | |
| 53217-216-60 | Lorazepam | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 53217-216-90 | Lorazepam | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-216-15 | EA - Each | 53217-216 | a6e950bd-b453-428c-84d0-0b86a29791e4 | 1 | 2016-12-07 |
| 53217-216-30 | EA - Each | 53217-216 | 919304ea-1ffd-479e-b2f1-d59fd3509061 | 1 | 2016-12-07 |
| 53217-216-60 | EA - Each | 53217-216 | 6dfe80c0-b1fb-4bcf-a2ec-0bac5502681e | 1 | 2016-12-07 |
| 53217-216-90 | EA - Each | 53217-216 | 86758c00-93ae-44b2-9a27-ca751e66c13b | 1 | 2016-12-07 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | 42b9bc57-cd3a-4ea3-9756-5b5476b30128 | 1 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | 42b9bc57-cd3a-4ea3-9756-5b5476b30128 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-216-15 | 53217021615 | 15 in 1 BOTTLE | Historical |
| 53217-216-30 | 53217021630 | 30 in 1 BOTTLE | Historical |
| 53217-216-45 | 53217021645 | 45 in 1 BOTTLE | Historical |
| 53217-216-60 | 53217021660 | 60 in 1 BOTTLE | Historical |
| 53217-216-90 | 53217021690 | 90 in 1 BOTTLE | Historical |