RISPERDAL CONSTA
- Product NDC
- 50458-307
- 11-digit product format
- 504580307
- Labeler code
- 50458
- Product ID
- 50458-307_42dc490b-4117-142a-e063-6294a90aeb21
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- risperidone
- Dosage form
- KIT
- Labeler
- Janssen Pharmaceuticals, Inc.
- Application
- NDA021346
- Marketing category
- NDA
- Marketing start
- 2003-10-29
- 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 |
|---|---|---|---|---|---|---|---|
| N021346-001 | RISPERDAL CONSTA | RISPERIDONE | 25MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 |
| N021346-002 | RISPERDAL CONSTA | RISPERIDONE | 37.5MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 |
| N021346-003 | RISPERDAL CONSTA | RISPERIDONE | 50MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 |
| N021346-004 | RISPERDAL CONSTA | RISPERIDONE | 12.5MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2007-04-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021346-001 | AB |
| N021346-002 | AB |
| N021346-003 | AB |
| N021346-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | POWDER / INTRAMUSCULAR | AB | RLD, RS | 2007-04-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-001 | RISPERDAL CONSTA | 25MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD, RS | 2003-10-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-002 | RISPERDAL CONSTA | 37.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-003 | RISPERDAL CONSTA | 50MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2003-10-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-004 | RISPERDAL CONSTA | 12.5MG/VIAL | INJECTABLE / INTRAMUSCULAR | AB | RLD | 2007-04-12 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021346-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021346-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021346-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021346-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021346-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021346-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021346-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021346-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021346-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021346-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021346-004 | AB | 1 | d06236e962d9… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021346-001 | 6194006*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-001 | 6379703*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-001 | 6596316*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-001 | 6667061 | 2020-05-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-001 | 6667061*PED | 2020-11-25 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-002 | 6194006*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-002 | 6379703*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-002 | 6596316*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-002 | 6667061 | 2020-05-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-002 | 6667061*PED | 2020-11-25 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-003 | 6194006*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-003 | 6379703*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-003 | 6596316*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-003 | 6667061 | 2020-05-25 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-003 | 6667061*PED | 2020-11-25 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-004 | 6194006*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-004 | 6379703*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021346-004 | 6596316*PED | 2019-06-30 | Pediatric extension | 74a2ff9319b5… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-001 | 6667061 | 2020-05-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-001 | 6667061*PED | 2020-11-25 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-002 | 6667061 | 2020-05-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-002 | 6667061*PED | 2020-11-25 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-003 | 6667061 | 2020-05-25 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021346-003 | 6667061*PED | 2020-11-25 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-001 | 6667061 | 2020-05-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-001 | 6667061*PED | 2020-11-25 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-002 | 6667061 | 2020-05-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-002 | 6667061*PED | 2020-11-25 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-003 | 6667061 | 2020-05-25 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021346-003 | 6667061*PED | 2020-11-25 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-001 | 6194006*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-001 | 6379703*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-001 | 6596316*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-001 | 6667061 | 2020-05-25 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-001 | 6667061*PED | 2020-11-25 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-002 | 6194006*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-002 | 6379703*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-002 | 6596316*PED | 2019-06-30 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-002 | 6667061 | 2020-05-25 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021346-002 | 6667061*PED | 2020-11-25 | Pediatric extension | 3f01610625f2… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RISPERDAL CONSTA
- Listing expiration
- 2026-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bb34ee82-d2c2-43b8-ba21-2825c0954691 | 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 |
|---|---|---|---|---|---|---|
| 50458-307-11 | RISPERDAL CONSTA | 1 in 1 BOX | KIT | 1 | 38 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-307-11 | EA - Each | 50458-307 | 13472037-7c58-4005-854a-8855c437879f | 1 | 2012-07-24 |
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 |
|---|---|---|---|---|---|---|
| RISPERDAL CONSTA | RISPERIDONE | Janssen Pharmaceuticals, Inc. | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | 021346 NDA021346 50458-307 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 706825 | RisperDAL CONSTA 12.5 MG Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706831 | RisperDAL CONSTA 25 MG Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706827 | RisperDAL CONSTA 37.5 MG Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706829 | RisperDAL CONSTA 50 MG Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706822 | risperiDONE 12.5 MG Extended Release Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402010 | risperiDONE 25 MG Extended Release Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402011 | risperiDONE 37.5 MG Extended Release Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402012 | risperiDONE 50 MG Extended Release Injection | PSN | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706825 | risperidone 12.5 MG Injection [Risperdal] | SBD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706831 | risperidone 25 MG Injection [Risperdal] | SBD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706827 | risperidone 37.5 MG Injection [Risperdal] | SBD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706829 | risperidone 50 MG Injection [Risperdal] | SBD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706822 | risperidone 12.5 MG Injection | SCD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402010 | risperidone 25 MG Injection | SCD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402011 | risperidone 37.5 MG Injection | SCD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 402012 | risperidone 50 MG Injection | SCD | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706825 | Risperdal 12.5 MG Injection | SY | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706831 | Risperdal 25 MG Injection | SY | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706827 | Risperdal 37.5 MG Injection | SY | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
| 706829 | Risperdal 50 MG Injection | SY | bb34ee82-d2c2-43b8-ba21-2825c0954691 | 38 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50458-307-11 | 50458030711 | 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-307-01) | 1 kit | 2003-10-29 | 0000-00-00 | No | No | Current |