risperidone
- Product NDC
- 65841-669
- 11-digit product format
- 658410669
- Labeler code
- 65841
- Product ID
- 65841-669_d39bd21c-64bb-4eff-8713-5a5ed9b98c9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA078040
- Marketing category
- ANDA
- Marketing start
- 2008-11-12
- 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 |
|---|---|---|---|---|---|---|---|
| A078040-001 | RISPERIDONE | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | |
| A078040-002 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | |
| A078040-003 | RISPERIDONE | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | |
| A078040-004 | RISPERIDONE | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | |
| A078040-005 | RISPERIDONE | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | |
| A078040-006 | RISPERIDONE | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078040-001 | AB |
| A078040-002 | AB |
| A078040-003 | AB |
| A078040-004 | AB |
| A078040-005 | AB |
| A078040-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2008-10-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2008-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2008-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2008-10-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2008-10-16 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078040-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078040-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078040-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078040-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078040-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078040-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078040-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078040-004 | AB | 1 | 2680178bc6a6… |
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 |
|---|---|
| 23993d21-80bf-41c4-b57d-88a620173b6b | 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 |
|---|---|---|---|---|---|---|
| 65841-669-01 | risperidone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 9 | |
| 65841-669-05 | risperidone | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 9 | |
| 65841-669-06 | risperidone | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 9 | |
| 65841-669-10 | risperidone | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 9 | |
| 65841-669-14 | risperidone | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 9 | |
| 65841-669-16 | risperidone | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 9 |
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 | Cardinal Health 107, LLC | 3ce21196-4aa0-469b-8f04-6650b2c48cb5 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 078040 ANDA078040 |
| risperidone | RISPERIDONE | Major Pharmaceuticals | d5abd75f-7f4a-4a7d-b849-82fce88f5ff7 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 078040 ANDA078040 |
| Risperidone | RISPERIDONE | American Health Packaging | f11dae15-b057-4258-9229-3819d0c980fe | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | 078040 ANDA078040 |
| risperidone | RISPERIDONE | Zydus Pharmaceuticals USA Inc. | 713b5ac7-53d6-4139-8599-3028f789de4b | 2025-06-14 | Boxed warning, Warnings, Adverse reactions | 078040 ANDA078040 |
| risperidone | RISPERIDONE | Zydus Lifesciences Limited | 23993d21-80bf-41c4-b57d-88a620173b6b | 2024-08-12 | 078040 ANDA078040 65841-669 | |
| risperidone | RISPERIDONE | Proficient Rx LP | b611fe52-1787-47e6-8a6b-1999a4e4f22c | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 078040 ANDA078040 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312828 | risperiDONE 0.25 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312829 | risperiDONE 0.5 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312830 | risperiDONE 1 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312831 | risperiDONE 2 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312832 | risperiDONE 3 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 314211 | risperiDONE 4 MG Oral Tablet | PSN | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312828 | risperidone 0.25 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312829 | risperidone 0.5 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312830 | risperidone 1 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312831 | risperidone 2 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 312832 | risperidone 3 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
| 314211 | risperidone 4 MG Oral Tablet | SCD | 23993d21-80bf-41c4-b57d-88a620173b6b | 9 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65841-669-01 | 65841066901 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-669-01) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-669-05 | 65841066905 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-669-05) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-669-06 | 65841066906 | 30 TABLET, FILM COATED in 1 BOTTLE (65841-669-06) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-669-10 | 65841066910 | 1000 TABLET, FILM COATED in 1 BOTTLE (65841-669-10) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-669-14 | 65841066914 | 60 TABLET, FILM COATED in 1 BOTTLE (65841-669-14) | 2008-11-13 | 0000-00-00 | No | No | Current |
| 65841-669-16 | 65841066916 | 90 TABLET, FILM COATED in 1 BOTTLE (65841-669-16) | 2008-11-13 | 0000-00-00 | No | No | Current |