CLOZAPINE
- Product NDC
- 65862-845
- 11-digit product format
- 658620845
- Labeler code
- 65862
- Product ID
- 65862-845_a46da176-2ed3-4b9a-b06f-efab2936a5ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLOZAPINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206433
- Marketing category
- ANDA
- Marketing start
- 2016-11-29
- Substance
- CLOZAPINE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- 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 product | product | 65862-845 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | ||
| unfinished package | package | 65862-845 | 65862-845-59 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-845-59 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-845-59 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-845-59 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-845-59 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-845-59 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-845-59 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-845-59 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-845-59 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-845-59 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-845-59 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-845-59 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-845-59 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-845-59 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-845-59 | 50b4072663b7… | eae3003ed65e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206433-001 | CLOZAPINE | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | |
| A206433-002 | CLOZAPINE | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | |
| A206433-003 | CLOZAPINE | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | |
| A206433-004 | CLOZAPINE | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206433-001 | AB |
| A206433-002 | AB |
| A206433-003 | AB |
| A206433-004 | 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 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-001 | CLOZAPINE | 25MG | TABLET / ORAL | AB | 2016-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-002 | CLOZAPINE | 50MG | TABLET / ORAL | AB | 2016-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-003 | CLOZAPINE | 100MG | TABLET / ORAL | AB | 2016-11-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-004 | CLOZAPINE | 200MG | TABLET / ORAL | AB | 2016-11-29 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206433-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206433-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206433-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206433-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206433-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206433-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206433-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206433-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206433-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206433-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206433-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206433-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206433-004 | AB | 1 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CLOZAPINE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOZAPINE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| J60AR2IKIC | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5021d643-32d2-4167-b5d8-90870e68a787 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fde12e54-43fa-cc16-3015-4c000a7b8d3e | Product name | 5 | 20250812 |
| 0901063f-b37f-4bf1-8be6-1e2a469e57bc | Product name | 2 | 20180209 |
| e01fb60f-a608-2c68-dfdd-23e6433ece68 | Product name | 5 | 20180209 |
| 7a7f58c4-be43-7e82-4dfc-128bbed4230a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-845-01 | CLOZAPINE | 100 in 1 BOTTLE | TABLET | 100 | 15 | |
| 65862-845-05 | CLOZAPINE | 500 in 1 BOTTLE | TABLET | 500 | 15 | |
| 65862-845-10 | CLOZAPINE | 10 in 1 BLISTER PACK | TABLET | 10 | 15 | |
| 65862-845-78 | CLOZAPINE | 10 in 1 CARTON | TABLET | 10 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-845-01 | EA - Each | 65862-845 | e06e9b73-1e19-4640-a26d-4009dea295fb | 1 | 2017-05-04 |
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 |
|---|---|---|---|---|---|---|
| CLOZAPINE | CLOZAPINE | NorthStar Rx LLC | 61fe53d5-ed5c-4e45-9189-709d08d386cb | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 206433 ANDA206433 |
| CLOZAPINE | CLOZAPINE | Cardinal Health 107, LLC | 7c748f8a-73ce-4bd3-aa30-9c66657f06ec | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 206433 ANDA206433 |
| CLOZAPINE | CLOZAPINE | Major Pharmaceuticals | 9db7aefb-f607-4158-a310-181e631bc648 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 206433 ANDA206433 |
| CLOZAPINE | CLOZAPINE | Aurobindo Pharma Limited | 5021d643-32d2-4167-b5d8-90870e68a787 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 206433 ANDA206433 65862-845 |
| Clozapine | CLOZAPINE | American Health Packaging | d36c298b-7292-46e0-898f-43d3e11c3cf4 | 2025-09-03 | Boxed warning, Warnings, Adverse reactions | 206433 ANDA206433 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-845-01 | 65862084501 | 100 TABLET in 1 BOTTLE (65862-845-01) | 100 tablet | 2016-11-29 | 0000-00-00 | No | No | Current |
| 65862-845-05 | 65862084505 | 500 TABLET in 1 BOTTLE (65862-845-05) | 500 tablet | 2016-11-29 | 0000-00-00 | No | No | Current |
| 65862-845-10 | 65862084510 | 10 in 1 BLISTER PACK | Historical | |||||
| 65862-845-59 | 65862084559 | 5000 TABLET in 1 BAG (65862-845-59) | 5000 tablet | 10-JAN-24 | Current | |||
| 65862-845-78 | 65862084578 | 10 BLISTER PACK in 1 CARTON (65862-845-78) / 10 TABLET in 1 BLISTER PACK (65862-845-10) | 10 blister pack | 2016-11-29 | 0000-00-00 | No | No | Current |