LORAZEPAM
- Product NDC
- 61919-062
- 11-digit product format
- 619190062
- Labeler code
- 61919
- Product ID
- 61919-062_47e14ab4-5eb4-67c7-e063-6394a90a1e4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LORAZEPAM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA078203
- Marketing category
- ANDA
- Marketing start
- 2017-02-10
- Substance
- LORAZEPAM
- Active strength
- .5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 | 61919-062 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded product | product | 61919-062 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 61919-062 | 61919-062-30 | I | Inactivated by FDA | 2026-08-03 | |
| excluded package | package | 61919-062 | 61919-062-90 | I | Inactivated by FDA | 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 | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 61919-062-90 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 61919-062-60 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 61919-062-60 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 61919-062-60 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078203-001 | LORAZEPAM | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | |
| A078203-002 | LORAZEPAM | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | |
| A078203-003 | LORAZEPAM | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078203-001 | AB |
| A078203-002 | AB |
| A078203-003 | 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 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-002 | LORAZEPAM | 1MG | TABLET / ORAL | AB | 2007-07-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-003 | LORAZEPAM | 2MG | TABLET / ORAL | AB | 2007-07-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078203-001 | LORAZEPAM | 0.5MG | TABLET / ORAL | AB | 2007-07-30 | 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 | A078203-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078203-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078203-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078203-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078203-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078203-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078203-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078203-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078203-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078203-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078203-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078203-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078203-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078203-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078203-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LORAZEPAM
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LORAZEPAM | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| O26FZP769L | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 197900 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4832f02d-289c-2fe6-e054-00144ff8d46c | Available on FDA.report |
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 |
|---|---|---|---|---|---|
| 61919-062-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1dd5-a910-e053-dadaa90a0b85 | Lorazepam |
| 61919-062-60 | 2020-12-14 | C162847 | 48780-1 | 9d75b9cf-d259-f424-e053-dadaa90a57ce | LORAZEPAM |
| 61919-062-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d259-f424-e053-dadaa90a57ce | LORAZEPAM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-062-02 | LORAZEPAM | 2 in 1 BOTTLE | TABLET | 2 | 5 | |
| 61919-062-60 | LORAZEPAM | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 61919-062-30 | Lorazepam | 30 in 1 BOTTLE | TABLET | 30 | 4 | |
| 61919-062-90 | Lorazepam | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61919-062-02 | EA - Each | 61919-062 | 96c29765-9686-4a8a-b755-db9f7d549848 | 1 | 2022-02-07 |
| 61919-062-60 | EA - Each | 61919-062 | 8cf41b41-b460-439c-a7cf-1721b20f0175 | 1 | 2017-04-05 |
| 61919-062-90 | EA - Each | 61919-062 | 278f8d8e-9c2f-4170-af47-34b9c80c3a27 | 1 | 2019-08-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-062 | LORAZEPAM TABLET [DIRECT RX] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240110_4832f02d-289c-2fe6-e054-00144ff8d46c.zip |
| 61919-062 | LORAZEPAM TABLET [DIRECT_RX] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240110_8e4a2ed9-265c-1be3-e053-2995a90a4250.zip |
| 61919-062 | LORAZEPAM TABLET [DIRECT_RX] | 1 | Current NDC, Legacy NDC, 1 package rows | 20190703_8cb6b6e8-66ff-46f1-e053-2a95a90a3fd3.zip |
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. | be9f8bda-1cd9-40a6-a4da-b5961389fb5b | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | d6364be4-056b-4ebe-83bc-3fc85e8f488c | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | b707ecb2-644c-4323-ab0e-7bc5929cd560 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | 0cd02e52-ead5-4b2a-9708-c7c4be7b7995 | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Coupler LLC | 5114810c-025f-6113-e063-6294a90af538 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | 1009c870-fd98-4e3b-81c8-4184036fb8c2 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | A-S Medication Solutions | 8361519b-be1a-4542-a782-d7cdfa153e86 | 2026-01-24 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | REMEDYREPACK INC. | a0a33933-f697-4d3b-ba99-8a995a4b6c6b | 2026-01-09 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| LORAZEPAM | LORAZEPAM | DIRECT RX | 4832f02d-289c-2fe6-e054-00144ff8d46c | 2026-01-08 | Warnings, Adverse reactions | 078203 ANDA078203 61919-062 |
| Lorazepam | LORAZEPAM | RedPharm Drug, Inc. | 891b2c10-942f-0e4d-e053-2995a90af028 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | PharmPak, Inc. | b6e4d2c7-10c0-4d77-be7b-caa3d3b86997 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | PD-Rx Pharmaceuticals, Inc. | 0681c8db-ff09-4258-a5e0-76a26b0ea0af | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | Major Pharmaceuticals | 62f6eb3b-813d-4890-aca9-799b7fa890df | 2025-01-21 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4a66b854-4dd6-3746-e054-00144ff8d46c | 2025-01-20 | Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 503834f9-fa2e-5e23-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | A-S Medication Solutions | be85b116-9f09-403a-8e0d-e77e344d3a9a | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4a66b854-4dc1-3746-e054-00144ff8d46c | 2024-10-08 | Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 4ab77192-8fe9-2965-e054-00144ff88e88 | 2024-07-19 | Warnings, Adverse reactions | 078203 ANDA078203 |
| Lorazepam | LORAZEPAM | NuCare Pharmaceuticals, Inc. | 50379c41-2676-590c-e054-00144ff8d46c | 2024-07-08 | Warnings, Adverse reactions | 078203 ANDA078203 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | 4832f02d-289c-2fe6-e054-00144ff8d46c | 5 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | 4832f02d-289c-2fe6-e054-00144ff8d46c | 5 |
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | 8e4a2ed9-265c-1be3-e053-2995a90a4250 | 4 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | 8e4a2ed9-265c-1be3-e053-2995a90a4250 | 4 |
| 197900 | LORazepam 0.5 MG Oral Tablet | PSN | 8cb6b6e8-66ff-46f1-e053-2a95a90a3fd3 | 1 |
| 197900 | lorazepam 0.5 MG Oral Tablet | SCD | 8cb6b6e8-66ff-46f1-e053-2a95a90a3fd3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61919-062-02 | 61919006202 | 2 TABLET in 1 BOTTLE (61919-062-02) | 2 tablet | 2017-02-10 | 0000-00-00 | No | No | Current |
| 61919-062-30 | 61919006230 | 30 TABLET in 1 BOTTLE (61919-062-30) | 30 tablet | 2019-07-22 | 0000-00-00 | No | No | Current |
| 61919-062-60 | 61919006260 | 60 TABLET in 1 BOTTLE (61919-062-60) | 60 tablet | 2017-02-10 | 0000-00-00 | No | No | Current |
| 61919-062-90 | 61919006290 | 90 in 1 BOTTLE | Historical |