RISPERIDONE
- Product NDC
- 67046-0635
- 11-digit product format
- 670460635
- Labeler code
- 67046
- Product ID
- 67046-0635_53d566be-8ff7-b778-e063-6394a90a3d7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RISPERIDONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA201003
- Marketing category
- ANDA
- Marketing start
- 2026-05-26
- Substance
- RISPERIDONE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201003-001 | RISPERIDONE | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-002 | RISPERIDONE | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-003 | RISPERIDONE | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-004 | RISPERIDONE | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-005 | RISPERIDONE | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | |
| A201003-006 | RISPERIDONE | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201003-001 | AB |
| A201003-002 | AB |
| A201003-003 | AB |
| A201003-004 | AB |
| A201003-005 | AB |
| A201003-006 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201003-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201003-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201003-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201003-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201003-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201003-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201003-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-004 | AB | 1 | b8a1b40f171c… |
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
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RISPERIDONE | 1 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L6UH7ZF8HC | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312830 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | Available on FDA.report |
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 | Proficient Rx LP | 2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 088dc3dd-7740-471b-8c06-5a47900ae5b5 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 1b5c9889-4dc3-48df-8629-4ac099e2b4c0 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Proficient Rx LP | 394c7e27-52a2-4d4c-8c6e-fe37b03266ae | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | ac152803-d75f-4c3c-bc49-8663b21a3a82 | 2019-04-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 67046-0635-3 | 67046063503 | 30 TABLET in 1 BLISTER PACK (67046-0635-3) | 30 tablet | 2026-05-26 | No | No | Current |