Lorazepam
- Product NDC
- 42254-113
- 11-digit product format
- 422540113
- Labeler code
- 42254
- Product ID
- 42254-113_706af4a6-6595-48f9-be93-d57da75702c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA078203
- Marketing category
- ANDA
- Marketing start
- 2009-10-09
- 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
- 2017-12-31
- 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 |
|---|---|---|---|---|---|
| 42254-113-05 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c83-c013-e053-90daa90a1393 | Lorazepam Tablets, USP |
| 42254-113-15 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c83-c013-e053-90daa90a1393 | Lorazepam Tablets, USP |
| 42254-113-30 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c83-c013-e053-90daa90a1393 | Lorazepam Tablets, USP |
| 42254-113-60 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c83-c013-e053-90daa90a1393 | Lorazepam Tablets, USP |
| 42254-113-90 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c83-c013-e053-90daa90a1393 | Lorazepam Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-113-05 | Lorazepam | 05 in 1 BOTTLE | TABLET | 05 | 1 | |
| 42254-113-15 | Lorazepam | 15 in 1 BOTTLE | TABLET | 15 | 1 | |
| 42254-113-30 | Lorazepam | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 42254-113-60 | Lorazepam | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 42254-113-90 | Lorazepam | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-113-05 | EA - Each | 42254-113 | 777b5786-ada3-41cf-a0db-b38ddc23c389 | 1 | 2013-03-03 |
| 42254-113-15 | EA - Each | 42254-113 | 1d1509f7-9d39-4aa1-9f91-3338a3f41f76 | 1 | 2013-03-03 |
| 42254-113-30 | EA - Each | 42254-113 | d9969ecd-04b8-4352-ab47-fc9011c21b24 | 1 | 2013-03-03 |
| 42254-113-60 | EA - Each | 42254-113 | 43c33043-d315-4c30-a75d-510749d1ec21 | 1 | 2013-03-03 |
| 42254-113-90 | EA - Each | 42254-113 | b3d62775-9306-4d6f-87f9-6e6374cda361 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORAZEPAM | ACTIVE INGREDIENT | O26FZP769L | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| LORAZEPAM | ACTIVE MOIETY | O26FZP769L | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | LORAZEPAM TABLET [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
| 197901 | LORazepam 1 MG Oral Tablet | PSN | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
| 197902 | LORazepam 2 MG Oral Tablet | PSN | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
| 197901 | lorazepam 1 MG Oral Tablet | SCD | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
| 197902 | lorazepam 2 MG Oral Tablet | SCD | 706af4a6-6595-48f9-be93-d57da75702c3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 42254-113-05 | 42254011305 | 05 in 1 BOTTLE | Historical |
| 42254-113-15 | 42254011315 | 15 in 1 BOTTLE | Historical |
| 42254-113-30 | 42254011330 | 30 in 1 BOTTLE | Historical |
| 42254-113-60 | 42254011360 | 60 in 1 BOTTLE | Historical |
| 42254-113-90 | 42254011390 | 90 in 1 BOTTLE | Historical |