Clonazepam
- Product NDC
- 43547-407
- 11-digit product format
- 435470407
- Labeler code
- 43547
- Product ID
- 43547-407_dc17b9d4-2890-4f6c-8476-daa39d0cbc9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clonazepam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare LLC
- Application
- ANDA077856
- Marketing category
- ANDA
- Marketing start
- 2018-02-15
- Substance
- CLONAZEPAM
- Active strength
- 1 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
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077856-001 | CLONAZEPAM | 0.5MG | TABLET / ORAL | AB | 2006-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077856-002 | CLONAZEPAM | 1MG | TABLET / ORAL | AB | 2006-06-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077856-003 | CLONAZEPAM | 2MG | TABLET / ORAL | AB | 2006-06-28 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077856-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077856-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077856-003 | AB | 1 | 84e616aacf4f… |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clonazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLONAZEPAM | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5PE9FDE8GB | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4acbb7a9-4db5-4497-b8db-9f358b3f6fb4 | 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 |
|---|---|---|---|---|---|---|
| 43547-407-10 | Clonazepam | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 9 | |
| 43547-407-11 | Clonazepam | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 9 | |
| 43547-407-50 | Clonazepam | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-407-10 | EA - Each | 43547-407 | 2a99980c-7163-47f2-aac0-c5108c834b99 | 1 | 2018-03-08 |
| 43547-407-11 | EA - Each | 43547-407 | 10200076-573b-4f3c-89f2-b4d8f431bea0 | 1 | 2018-03-08 |
| 43547-407-50 | EA - Each | 43547-407 | 0f9ea6ad-20b1-4cdb-8c4e-5dfaca9daae7 | 1 | 2018-03-08 |
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 | Bryant Ranch Prepack | f06dc5fc-94e0-496e-bdf0-11f2b6ffc786 | 2024-08-06 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 254a03c9-070c-40e6-83ac-524c1aec3b6b | 2024-08-05 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | NuCare Pharmaceuticals,Inc. | 19b1fe7b-8f7b-03b7-e063-6394a90a9ba5 | 2024-05-30 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 154806ed-91af-fc7f-e063-6294a90ae0f4 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 5ec3df57-1137-4402-84e6-28dd76286427 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 2cb46dc0-a03e-42d7-ba67-22319598389f | 2024-02-06 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | baa86bf1-75f3-44da-b67f-b6e4b5303f1e | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | cd364371-d2af-4cb4-a5df-3d3149580e16 | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | d732be07-6eb7-48f2-b6cd-28baad46aca5 | 2024-01-09 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 5f3a2f64-57ed-475c-9d8c-b2094bf1d79e | 2023-10-26 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 5ae98718-9da5-4edc-8efb-67b212577548 | 2023-10-18 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | cc14bb7b-d0c8-4f41-bcd9-a0c860b45a43 | 2023-10-18 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 645fb912-479c-46de-b99c-4ea341bfd9ba | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Bryant Ranch Prepack | 6960e994-e9ea-4a4a-b674-7e6124d8b381 | 2023-05-25 | Warnings, Adverse reactions | 077856 ANDA077856 |
| Clonazepam | CLONAZEPAM | Proficient Rx LP | 63286201-4b79-45b8-8f48-7e21dadc1408 | 2021-02-01 | Warnings, Adverse reactions | 077856 ANDA077856 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-407-10 | 43547040710 | 100 TABLET in 1 BOTTLE, PLASTIC (43547-407-10) | 100 tablet | 2018-02-15 | 0000-00-00 | No | No | Current |
| 43547-407-11 | 43547040711 | 1000 TABLET in 1 BOTTLE, PLASTIC (43547-407-11) | 1000 tablet | 2018-02-15 | 0000-00-00 | No | No | Current |
| 43547-407-50 | 43547040750 | 500 TABLET in 1 BOTTLE, PLASTIC (43547-407-50) | 500 tablet | 2018-02-15 | 0000-00-00 | No | No | Current |