Risperidone
- Product NDC
- 63304-643
- 11-digit product format
- 633040643
- Labeler code
- 63304
- Product ID
- 63304-643_8c155c45-e5c8-4358-90da-8f6d193ad88b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Risperidone
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA078474
- Marketing category
- ANDA
- Marketing start
- 2010-08-06
- Substance
- RISPERIDONE
- Active strength
- 3 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- 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 |
|---|---|---|---|---|---|---|---|
| A078474-001 | RISPERIDONE | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | |
| A078474-002 | RISPERIDONE | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078474-001 | AB |
| A078474-002 | 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 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078474-001 | RISPERIDONE | 3MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078474-002 | RISPERIDONE | 4MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2010-08-06 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A078474-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078474-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078474-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078474-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078474-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078474-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078474-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078474-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078474-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078474-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078474-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078474-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078474-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078474-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078474-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078474-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078474-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078474-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078474-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078474-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078474-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078474-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078474-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078474-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078474-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078474-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078474-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078474-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078474-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078474-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078474-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078474-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078474-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078474-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078474-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078474-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078474-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078474-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078474-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078474-002 | AB | 1 | 74a2ff9319b5… |
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
- Risperidone
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RISPERIDONE | 3 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L6UH7ZF8HC | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f91f551e-926f-440d-83d2-357e9d7484fe | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6ab2126a-0ca2-c16c-ab6d-b3a031ba7ac6 | Product name | 5 | 20250303 |
| 0efa9fd6-2fb6-4cd3-8b0f-2a2bf9c4a09e | Product name | 1 | 20250128 |
| e457a910-2c3a-4bfd-90b9-0310982c50dd | Product name | 1 | 20241218 |
| 42b1a2d5-888a-4386-ab9f-0979e0d7b4aa | Product name | 1 | 20231010 |
| 66685e90-862d-4873-a0c5-2be73b803c36 | Product name | 1 | 20230921 |
| 92d220a1-2a4c-4393-9080-7335ca8223cc | Product name | 1 | 20230823 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63304-643-05 | Risperidone | 500 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 500 | 11 | |
| 63304-643-11 | Risperidone | 1 in 1 POUCH | TABLET, ORALLY DISINTEGRATING | 1 | 11 | |
| 63304-643-17 | Risperidone | 10 in 1 BOX, UNIT-DOSE | TABLET, ORALLY DISINTEGRATING | 10 | 11 | |
| 63304-643-30 | Risperidone | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 11 | |
| 63304-643-69 | Risperidone | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | 11 | |
| 63304-643-69 | Risperidone | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 11 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Risperidone | RISPERIDONE | Sun Pharmaceutical Industries, Inc. | f91f551e-926f-440d-83d2-357e9d7484fe | 2022-07-13 | Boxed warning, Warnings, Adverse reactions | 078474 ANDA078474 63304-643 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 403825 | risperiDONE 0.5 MG Disintegrating Oral Tablet | PSN | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 401953 | risperiDONE 1 MG Disintegrating Oral Tablet | PSN | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 401954 | risperiDONE 2 MG Disintegrating Oral Tablet | PSN | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 616698 | risperiDONE 3 MG Disintegrating Oral Tablet | PSN | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 616705 | risperiDONE 4 MG Disintegrating Oral Tablet | PSN | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 403825 | risperidone 0.5 MG Disintegrating Oral Tablet | SCD | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 401953 | risperidone 1 MG Disintegrating Oral Tablet | SCD | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 401954 | risperidone 2 MG Disintegrating Oral Tablet | SCD | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 616698 | risperidone 3 MG Disintegrating Oral Tablet | SCD | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
| 616705 | risperidone 4 MG Disintegrating Oral Tablet | SCD | f91f551e-926f-440d-83d2-357e9d7484fe | 11 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63304-643-05 | 63304064305 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05) | 2010-08-06 | 0000-00-00 | No | No | Current | |
| 63304-643-11 | 63304064311 | 1 in 1 POUCH | Historical | |||||
| 63304-643-17 | 63304064317 | 10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11) | 10 pouch | 2010-08-06 | 0000-00-00 | No | No | Current |
| 63304-643-30 | 63304064330 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-30) | 2010-08-06 | 0000-00-00 | No | No | Current | |
| 63304-643-69 | 63304064369 | 1 BLISTER PACK in 1 CARTON (63304-643-69) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2010-08-06 | 0000-00-00 | No | No | Current |