RISPERIDONE
- Product NDC
- 70518-1631
- 11-digit product format
- 705181631
- Labeler code
- 70518
- Product ID
- 70518-1631_95691b69-2e2f-4c72-e053-2995a90a48af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- RISPERIDONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201003
- Marketing category
- ANDA
- Marketing start
- 2018-11-05
- Marketing end
- 0000-00-00
- Substance
- RISPERIDONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-1631 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-1631 | 70518-1631-0 | D | Discontinued by firm | 2026-08-03 |
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 |
|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-1631-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-1631-0 | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-005 | RISPERIDONE | 3MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-006 | RISPERIDONE | 4MG | TABLET / ORAL | AB | 2011-08-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-001 | RISPERIDONE | 0.25MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-002 | RISPERIDONE | 0.5MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-003 | RISPERIDONE | 1MG | TABLET / ORAL | AB | 2011-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-004 | RISPERIDONE | 2MG | TABLET / ORAL | AB | 2011-08-24 | 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 | 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… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201003-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201003-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201003-004 | AB | 1 | 2680178bc6a6… |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1631 | RISPERIDONE TABLET [REMEDYREPACK INC.] | 9 | Legacy NDC | 20250124_f789b6a8-831b-470a-8a66-e85e687da724.zip |
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 | Coupler LLC | 5643c32b-310e-4888-e063-6394a90ab62f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee495f20-c668-4d8f-9684-1029a4f232db | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 03d3b52d-3a7d-4595-84c9-332da6ca9171 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Coupler LLC | 52bb35ac-1f7d-bfbe-e063-6294a90aa2b9 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | a6767972-2d3f-482b-80bd-ac93e28fdd05 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 2776a647-678d-465c-9db3-4a9459ce779e | 2026-01-28 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 5d9519af-5a5e-47ce-8a0f-9b9cfac00e19 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | ee7d6779-7421-4761-99d2-ccbfde9385a8 | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | REMEDYREPACK INC. | 101b2d4d-4740-4225-94bc-aecc05d82c6b | 2026-01-26 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Ajanta Pharma USA Inc. | 095630bd-a77e-434e-94ee-f13da445d8f2 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | PD-Rx Pharmaceuticals, Inc. | be388943-fe0c-4c82-ac8e-3df9f77b2891 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| Risperidone | RISPERIDONE | Direct_Rx | 0b784f21-fc02-6542-e063-6294a90a285e | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | NuCare Pharmaceuticals,Inc. | 79648a52-1364-c25b-e053-2a91aa0a8ea4 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 420cfeef-0061-43b9-9491-dbd6ad866e55 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | aab773b2-a605-4cf8-a301-57e390fe67a6 | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | 2f83d3e9-04ab-4b24-ad1f-7ed2e784298a | 2024-05-29 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Bryant Ranch Prepack | e35be034-6275-41fb-bec4-9ae451458701 | 2024-04-11 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | A-S Medication Solutions | 523d4f99-1d6f-413f-9d6e-2ca430aaac14 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |
| RISPERIDONE | RISPERIDONE | Aphena Pharma Solutions - Tennessee, LLC | bda104ac-1eea-4a1a-836a-24bcc034b90f | 2022-11-09 | Boxed warning, Warnings, Adverse reactions | 201003 ANDA201003 |