Clonazepam
- Product NDC
- 59651-722
- Requested package NDC
- 59651-722-61
- 11-digit product format
- 596510722
- Labeler code
- 59651
- Product ID
- 59651-722_b1582eb7-af35-45d5-a52e-0e380d08527d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clonazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA075150
- Marketing category
- ANDA
- Marketing start
- 2023-01-17
- Substance
- CLONAZEPAM
- Active strength
- .5 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 |
|---|---|---|---|---|---|---|---|
| unfinished package | package | 59651-722 | 59651-722-61 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 |
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 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075150-001 | CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | |
| A075150-002 | CLONAZEPAM | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | |
| A075150-003 | CLONAZEPAM | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075150-001 | AB |
| A075150-002 | AB |
| A075150-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 1998-10-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 1998-10-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075150-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 1998-10-05 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075150-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075150-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075150-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075150-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075150-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075150-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075150-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075150-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075150-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075150-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075150-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075150-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075150-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075150-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075150-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075150-001 | AB | 1 | 1e350fbaab3a… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clonazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONAZEPAM | .5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5PE9FDE8GB | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b1582eb7-af35-45d5-a52e-0e380d08527d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f8e2a02d-e7b1-29aa-eb39-98a679441d91 | Product name | 3 | 20190927 |
| dc4336d1-53d4-d410-38d3-71aa2ce4749b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59651-722-01 | Clonazepam | 100 in 1 BOTTLE | TABLET | 100 | 1 | |
| 59651-722-99 | Clonazepam | 1000 in 1 BOTTLE | TABLET | 1000 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59651-722-01 | EA - Each | 59651-722 | 033c0b03-c6e9-475f-adfa-a76f9285efd7 | 1 | 2023-06-06 |
| 59651-722-99 | EA - Each | 59651-722 | 729b939e-ffe8-4c2e-bea6-b4e32bc3ec99 | 1 | 2023-06-06 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 1fb0807c-dccd-47a5-ada4-91418c4f47f5 | 2026-06-11 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | f613573a-3e8b-4abf-af69-0268f3d6f481 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 2606ecf9-3d71-4c1c-bfda-d7d98ffc6011 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 44f39aa8-a7bc-4e42-977c-31583e6388ae | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | dec8b5b2-2490-4880-a8d1-707b57954297 | 2025-06-20 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 214e760b-c909-bd93-e063-6294a90ae74a | 2024-10-22 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 20b3125e-4489-3c53-e063-6294a90a6539 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | 04db0fbe-7fa3-28af-e063-6294a90abbe6 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 |
| Clonazepam | CLONAZEPAM | Aurobindo Pharma Limited | b1582eb7-af35-45d5-a52e-0e380d08527d | 2023-02-02 | Boxed warning, Warnings, Adverse reactions | 075150 ANDA075150 59651-722 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Status |
|---|---|---|---|---|---|
| 59651-722-61 | 59651072261 | 6000 TABLET in 1 BAG (59651-722-61) | 6000 tablet | 17-JAN-23 | Current |