Zolmitriptan OD
- Product NDC
- 59746-462
- Requested package NDC
- 59746-462-13
- 11-digit product format
- 597460462
- Labeler code
- 59746
- Product ID
- 59746-462_5d9c2d59-8564-44d8-bd79-0e0b34ec50bd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolmitriptan
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Jubilant Cadista Pharmacuticals Inc.
- Application
- ANDA202956
- Marketing category
- ANDA
- Marketing start
- 2015-09-17
- Substance
- ZOLMITRIPTAN
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202956-001 | ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | |
| A202956-002 | ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202956-001 | AB |
| A202956-002 | 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 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202956-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202956-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2015-09-17 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202956-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202956-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202956-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202956-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202956-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202956-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202956-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202956-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202956-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202956-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202956-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202956-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202956-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202956-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202956-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202956-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202956-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202956-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202956-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202956-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202956-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202956-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202956-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202956-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202956-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202956-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202956-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202956-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202956-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202956-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202956-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202956-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202956-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202956-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202956-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202956-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202956-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202956-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202956-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202956-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolmitriptan OD
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZOLMITRIPTAN | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2FS66TH3YW | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a0fbe307-6e31-a71d-5232-3216747b9b34 | Product name | 2 | 20220316 |
| 49286735-675f-7ca8-3815-48cfc7bb5a5a | Product name | 9 | 20180828 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59746-462-13 | Zolmitriptan OD | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | 7 | |
| 59746-462-13 | Zolmitriptan OD | 3 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 3 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59746-462-13 | EA - Each | 59746-462 | 96ad6f15-3f5d-4882-b44e-32736f83645f | 1 | 2017-06-15 |
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 |
|---|---|---|---|---|---|---|
| Zolmitriptan OD | ZOLMITRIPTAN | Jubilant Cadista Pharmacuticals Inc. | a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | 2025-10-07 | Warnings, Adverse reactions | 202956 ANDA202956 59746-462-13 59746-462 59746046213 |
| Zolmitriptan OD | ZOLMITRIPTAN | AvKARE | 3f0040a6-b1d6-3d73-e063-6294a90af23c | 2025-09-17 | Warnings, Adverse reactions | 202956 ANDA202956 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 284201 | ZOLMitriptan 2.5 MG Disintegrating Oral Tablet | PSN | a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | 7 |
| 351134 | ZOLMitriptan 5 MG Disintegrating Oral Tablet | PSN | a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | 7 |
| 284201 | zolmitriptan 2.5 MG Disintegrating Oral Tablet | SCD | a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | 7 |
| 351134 | zolmitriptan 5 MG Disintegrating Oral Tablet | SCD | a6a32fc6-4243-9cdd-91c7-b8a58e0f9811 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59746-462-13 | 59746046213 | 1 BLISTER PACK in 1 CARTON (59746-462-13) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 1 blister pack | 2015-09-17 | 0000-00-00 | No | No | Current |