Clonazepam
- Product NDC
- 70518-2392
- 11-digit product format
- 705182392
- Labeler code
- 70518
- Product ID
- 70518-2392_c8bdb38e-1d94-b42b-e053-2a95a90af9aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clonazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA077856
- Marketing category
- ANDA
- Marketing start
- 2019-10-26
- Marketing end
- 0000-00-00
- Substance
- CLONAZEPAM
- 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 | 70518-2392 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 70518-2392 | 70518-2392-0 | D | Discontinued by firm | 2026-08-17 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077856-001 | CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | |
| A077856-002 | CLONAZEPAM | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | |
| A077856-003 | CLONAZEPAM | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077856-001 | AB |
| A077856-002 | AB |
| A077856-003 | 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 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 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 | A077856-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077856-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077856-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077856-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077856-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077856-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077856-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077856-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077856-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077856-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077856-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077856-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077856-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077856-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077856-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077856-001 | AB | 1 | 1e350fbaab3a… |
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 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-03-09 | CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only |
| 2023-03-09 | CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only |
| 2023-01-30 | CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg CIV Rx only |
| 2023-01-30 | CLONAZEPAM TABLETS, USP 0.5 mg, 1 mg and 2 mg Rx only |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-2392-0 | EA - Each | 70518-2392 | 53b40a1a-ad3f-41a7-b02b-097038a75dbc | 1 | 2026-01-08 |
| 70518-2392-1 | EA - Each | 70518-2392 | 0b5f02b9-7eb5-4f4e-af30-48a799552dff | 1 | 2026-01-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2392 | CLONAZEPAM TABLET [REMEDYREPACK INC.] | 7 | Legacy NDC | 20250316_6a051f02-5826-4f9e-bb9c-5b5520796803.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 |
|---|---|---|---|---|---|---|
| Clonazepam | CLONAZEPAM | REMEDYREPACK INC. | 533a12a8-64fb-494f-a2a4-da1515ef1908 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Major Pharmaceuticals | 34366dd2-432c-4fa9-8fab-832cca781b84 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Coupler LLC | 511216c7-6878-f90a-e063-6394a90aaac8 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Cardinal Health 107, LLC | 5ad315f2-fa09-4956-b931-f9966fb73e4e | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 2fe0d214-9c4d-4a0c-9024-c2076c092c1a | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 87f362a7-cf66-4166-af51-ac2da473cf6b | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Preferred Pharmaceuticals Inc. | 939dee35-3987-4ce2-9985-3751ceffa20e | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | AvPAK | f2662808-01c4-330c-e053-2a95a90aa335 | 2026-02-24 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 08d0a109-3307-47b5-8ff2-c0ad83e66f08 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | 9a74ea97-1c00-4d96-a06f-81c183943dc6 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | PD-Rx Pharmaceuticals, Inc. | ca79f244-7e6e-4612-af26-e6e5cefbd3a2 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Solco Healthcare LLC | 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | American Health Packaging | c13297e2-ae3e-4198-b7c8-55fd672436aa | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Direct_Rx | fc75869c-cd6b-44a3-e053-6294a90a699e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| CLONAZEPAM | CLONAZEPAM | DIRECT RX | a821f647-be5f-274c-e053-2a95a90a23ce | 2025-01-17 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 263f99eb-9744-5601-e063-6394a90a47b1 | 2024-11-14 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 66bf60fa-61ac-47a7-a081-36077af9007e | 2024-10-14 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | b12661a6-2141-42a9-bcb0-c0aef81395ce | 2024-08-23 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | b83009c2-26ed-45fa-819e-164cdac264e6 | 2024-08-23 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 96518266-8f75-4301-b8fd-d2995a7f486d | 2024-08-06 | Warnings, Adverse reactions | 077856 ANDA077856 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-2392-0 | 70518239200 | 100 POUCH in 1 BOX, UNIT-DOSE (70518-2392-0) > 1 TABLET in 1 POUCH (70518-2392-1) | 100 pouch | 2019-10-26 | 0000-00-00 | No | No | Current |