Lorazepam
- Product NDC
- 33261-069
- 11-digit product format
- 332610069
- Labeler code
- 33261
- Product ID
- 33261-069_42ce3852-92b2-4637-89cf-a85b2e106ccf
- 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
- 2 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- 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 |
|---|---|---|---|---|---|
| 33261-069-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-24d2-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
| 33261-069-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-24d2-f424-e053-dadaa90a57ce | Lorazepam Tablets, USP CIV Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-069-30 | Lorazepam | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 33261-069-60 | Lorazepam | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-069-30 | EA - Each | 33261-069 | 5f2709ae-430a-4997-b0f0-254521f5c53a | 1 | 2015-10-02 |
| 33261-069-60 | EA - Each | 33261-069 | e28b7f18-b51d-4ed3-9d1b-89ac261485c7 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORAZEPAM | ACTIVE INGREDIENT | O26FZP769L | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LORAZEPAM | ACTIVE MOIETY | O26FZP769L | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | LORAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
| 197901 | LORazepam 1 MG Oral Tablet | PSN | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
| 197902 | LORazepam 2 MG Oral Tablet | PSN | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
| 197901 | lorazepam 1 MG Oral Tablet | SCD | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
| 197902 | lorazepam 2 MG Oral Tablet | SCD | ef3b64e1-4a79-44c4-b73a-0a86a1f910b4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-069-30 | 33261006930 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 33261-069-60 | 33261006960 | 60 in 1 BOTTLE, PLASTIC | Historical |