rizatriptan benzoate
- Product NDC
- 68462-467
- 11-digit product format
- 684620467
- Labeler code
- 68462
- Product ID
- 68462-467_120ff156-182f-41d2-82a1-f9ff7fd412c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- rizatriptan benzoate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA201914
- Marketing category
- ANDA
- Marketing start
- 2013-07-01
- Substance
- RIZATRIPTAN BENZOATE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 68462-467 | 68462-467-06 | D | Discontinued by firm | 2026-10-15 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201914-001 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | ||
| A201914-002 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | 2013-07-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201914-001 | RIZATRIPTAN BENZOATE | EQ 5MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A201914-002 | RIZATRIPTAN BENZOATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-07-01 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201914-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A201914-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201914-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A201914-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201914-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A201914-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201914-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A201914-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A201914-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A201914-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A201914-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A201914-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201914-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A201914-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A201914-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A201914-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A201914-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A201914-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A201914-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A201914-002 | AB | 1 | cb3db0bc1861… |
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
- rizatriptan benzoate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RIZATRIPTAN BENZOATE | 5 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f2791553-0b76-42f4-8d49-af3eda072bfb | Product name | 1 | 20251117 |
| 707ffe6e-db52-42b0-9a65-a0c00213f04f | Product name | 1 | 20231006 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 8b537454-32b8-7e64-1395-258682782d07 | Product name | 5 | 20170424 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-467-06 | rizatriptan benzoate | 6 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 6 | 13 | |
| 68462-467-46 | rizatriptan benzoate | 1 in 1 POUCH | TABLET, ORALLY DISINTEGRATING | 1 | 13 | |
| 68462-467-46 | rizatriptan benzoate | 3 in 1 BOX | TABLET, ORALLY DISINTEGRATING | 3 | 13 | |
| 68462-467-74 | rizatriptan benzoate | 4 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 4 | 13 | |
| 68462-467-74 | rizatriptan benzoate | 3 in 1 BOX | TABLET, ORALLY DISINTEGRATING | 3 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-467-06 | EA - Each | 68462-467 | 938dc7b2-35c5-4bd0-89bc-09ddbb56ab67 | 1 | 2013-08-02 |
| 68462-467-46 | EA - Each | 68462-467 | 5fc3afcb-9d29-425f-944f-41805b631f7f | 1 | 2017-04-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312837 | rizatriptan benzoate 10 MG Disintegrating Oral Tablet | PSN | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
| 312839 | rizatriptan benzoate 5 MG Disintegrating Oral Tablet | PSN | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
| 312837 | rizatriptan 10 MG Disintegrating Oral Tablet | SCD | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
| 312839 | rizatriptan 5 MG Disintegrating Oral Tablet | SCD | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
| 312837 | rizatriptan 10 MG (as rizatriptan benzoate 14.53 MG) Disintegrating Oral Tablet | SY | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
| 312839 | rizatriptan 5 MG (as rizatriptan benzoate 7.265 MG) Disintegrating Oral Tablet | SY | 4de33a24-db69-444a-b04d-c69ccba57ab2 | 13 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68462-467-06 | 68462046706 | 6 BOX in 1 CARTON (68462-467-06) > 3 POUCH in 1 BOX (68462-467-46) > 1 BLISTER PACK in 1 POUCH > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 6 box | 2013-07-01 | 0000-00-00 | No | No | Current |
| 68462-467-46 | 68462046746 | 1 in 1 POUCH | Historical | |||||
| 68462-467-74 | 68462046774 | 4 BOX in 1 CARTON (68462-467-74) / 3 POUCH in 1 BOX / 1 BLISTER PACK in 1 POUCH / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 4 box | 2013-07-01 | 0000-00-00 | No | No | Current |