Lorazepam
- Product NDC
- 63187-536
- 11-digit product format
- 631870536
- Labeler code
- 63187
- Product ID
- 63187-536_4250a0d9-3e57-4c09-aecb-e464bf7d97d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA071404
- Marketing category
- ANDA
- Marketing start
- 2007-01-04
- Marketing end
- 0000-00-00
- Substance
- LORAZEPAM
- Active strength
- 1 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63187-536 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 63187-536 | 63187-536-06 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63187-536 | 63187-536-15 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63187-536 | 63187-536-20 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63187-536 | 63187-536-30 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63187-536 | 63187-536-60 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 63187-536 | 63187-536-90 | D | Discontinued by firm | 2026-10-05 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-15 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-06 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-90 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-60 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63187-536-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-15 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-06 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-90 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-60 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63187-536-30 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-536-06 | EA - Each | 63187-536 | bf6ebe29-fb66-48de-a1c4-93fcb28b2f0f | 1 | 2016-11-08 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LORAZEPAM | ACTIVE INGREDIENT | O26FZP769L | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 | |
| LORAZEPAM | ACTIVE MOIETY | O26FZP769L | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 | |
| POLACRILIN POTASSIUM | INACTIVE INGREDIENT | 0BZ5A00FQU | LORAZEPAM TABLET [PROFICIENT RX LP] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63187-536-06 | 63187053606 | 6 TABLET in 1 BOTTLE (63187-536-06) | 6 tablet | 2016-09-01 | 0000-00-00 | No | No | Current |
| 63187-536-15 | 63187053615 | 15 TABLET in 1 BOTTLE (63187-536-15) | 15 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-536-20 | 63187053620 | 20 TABLET in 1 BOTTLE (63187-536-20) | 20 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-536-30 | 63187053630 | 30 TABLET in 1 BOTTLE (63187-536-30) | 30 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-536-60 | 63187053660 | 60 TABLET in 1 BOTTLE (63187-536-60) | 60 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-536-90 | 63187053690 | 90 TABLET in 1 BOTTLE (63187-536-90) | 90 tablet | 2015-09-01 | 0000-00-00 | No | No | Current |