Lorazepam
- Product NDC
- 63629-8185
- Requested package NDC
- 63629-8185-1
- 11-digit product format
- 636298185
- Labeler code
- 63629
- Product ID
- 63629-8185_e6376c74-c7f8-4c86-ae34-8f3438ae47e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lorazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA203572
- Marketing category
- ANDA
- Marketing start
- 2017-03-24
- Marketing end
- 0000-00-00
- Substance
- LORAZEPAM
- Active strength
- 2 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 package | package | 63629-8185 | 63629-8185-1 | D | Discontinued by firm | 2026-08-03 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203572-001 | LORAZEPAM | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | |
| A203572-002 | LORAZEPAM | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | |
| A203572-003 | LORAZEPAM | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203572-001 | AB |
| A203572-002 | AB |
| A203572-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2017-12-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2017-12-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A203572-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2017-12-22 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203572-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203572-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203572-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203572-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203572-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203572-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203572-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203572-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203572-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203572-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203572-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203572-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203572-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203572-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203572-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203572-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| LORAZEPAM | LORAZEPAM | REMEDYREPACK INC. | 7fa1a011-5e28-4b13-bcd2-5c5fc9b663b2 | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | Bryant Ranch Prepack | 46af8e93-3169-408a-b4d8-b8498642801d | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | Preferred Pharmaceuticals Inc. | 4a50329b-b272-4164-bddf-0d6cea3d7a23 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | 11372b3d-52c0-4694-8c88-4b72d3fda9d0 | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | PD-Rx Pharmaceuticals, Inc. | 0418ad09-3069-4381-9a8f-e41b234fdac6 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | Aurolife Pharma LLC | 5b851f67-309d-4ef3-8b4b-ade8908256ea | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | American Health Packaging | 45e31a87-a8db-4dda-b94b-83535b62e8e2 | 2025-09-14 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | Preferred Pharmaceuticals, Inc. | 00960fbd-a5da-408b-9867-62982f20906f | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | Preferred Pharmaceuticals, Inc. | 6cc1f35d-ff33-404e-aa5e-b01eab89863e | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 8aaf9bcb-7a4e-ffaa-e053-2995a90a3913 | 2025-01-31 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | DirectRx | ddcc0b2b-4be2-6d18-e053-2a95a90af987 | 2025-01-22 | Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | Advanced Rx of Tennessee, LLC | 2a57e549-390b-5482-e063-6394a90aeb3b | 2024-12-28 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 8fa33078-c379-41f5-e053-2995a90acced | 2024-10-09 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | Bryant Ranch Prepack | 853c762d-0772-4f02-99ca-0bc2911f09f0 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | a4fe8df0-3ce8-b8b8-e053-2995a90a28f4 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 8aace309-f3ef-6aef-e053-2995a90aa197 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals,Inc. | 933b5ef3-ec29-1a96-e053-2995a90a2d33 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | A-S Medication Solutions | 8602cef8-167e-4a8c-b10f-fc3295a3abcc | 2024-01-21 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 247110f2-5468-4593-8d86-41f8c869e03d | 2023-10-17 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
| LORAZEPAM | LORAZEPAM | A-S Medication Solutions | 823b1d71-a510-4d34-8015-60b55af23d78 | 2023-08-24 | Boxed warning, Warnings, Adverse reactions | 203572 ANDA203572 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63629-8185-1 | 63629818501 | 30 TABLET in 1 BOTTLE (63629-8185-1) | 30 tablet | 2019-07-19 | 0000-00-00 | No | No | Current |