Zolmitriptan
- Product NDC
- 68382-715
- 11-digit product format
- 683820715
- Labeler code
- 68382
- Product ID
- 68382-715_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Zolmitriptan
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA202890
- Marketing category
- ANDA
- Marketing start
- 2013-05-16
- Substance
- ZOLMITRIPTAN
- Active strength
- 2.5 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202890-001 | ZOLMITRIPTAN | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | |
| A202890-002 | ZOLMITRIPTAN | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202890-001 | AB |
| A202890-002 | 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 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | RS | 2013-05-15 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202890-001 | ZOLMITRIPTAN | 2.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202890-002 | ZOLMITRIPTAN | 5MG | TABLET, ORALLY DISINTEGRATING / ORAL | AB | 2013-05-15 | 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 | A202890-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202890-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202890-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202890-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202890-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202890-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202890-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202890-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202890-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202890-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202890-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202890-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202890-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202890-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202890-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202890-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202890-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202890-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202890-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A202890-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202890-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202890-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202890-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202890-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202890-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202890-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202890-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A202890-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202890-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202890-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202890-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A202890-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202890-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A202890-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202890-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A202890-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202890-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A202890-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202890-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A202890-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zolmitriptan
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZOLMITRIPTAN | 2.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2FS66TH3YW | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68382-715-01 | Zolmitriptan | 100 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 100 | 8 | |
| 68382-715-06 | Zolmitriptan | 30 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 30 | 8 | |
| 68382-715-10 | Zolmitriptan | 1000 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 1000 | 8 | |
| 68382-715-16 | Zolmitriptan | 90 in 1 BOTTLE | TABLET, ORALLY DISINTEGRATING | 90 | 8 | |
| 68382-715-30 | Zolmitriptan | 10 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 10 | 8 | |
| 68382-715-69 | Zolmitriptan | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 8 | |
| 68382-715-77 | Zolmitriptan | 10 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 10 | 8 | |
| 68382-715-86 | Zolmitriptan | 1 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68382-715-69 | EA - Each | 68382-715 | e1f8c5bb-1ca2-43d7-8ea7-939f3ae62f28 | 1 | 2013-06-04 |
| 68382-715-86 | EA - Each | 68382-715 | 414ce252-cb94-4f7c-bd5b-f306f25224f4 | 1 | 2013-06-04 |
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 | ZOLMITRIPTAN | Zydus Lifesciences Limited | aae2d9cb-9938-4032-961f-f0afd1958b5d | 2024-08-14 | 202890 ANDA202890 | |
| Zolmitriptan | ZOLMITRIPTAN | Zydus Pharmaceuticals USA Inc. | 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 2023-11-08 | Warnings, Adverse reactions | 202890 ANDA202890 68382-715 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 284201 | ZOLMitriptan 2.5 MG Disintegrating Oral Tablet | PSN | 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 8 |
| 351134 | ZOLMitriptan 5 MG Disintegrating Oral Tablet | PSN | 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 8 |
| 284201 | zolmitriptan 2.5 MG Disintegrating Oral Tablet | SCD | 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 8 |
| 351134 | zolmitriptan 5 MG Disintegrating Oral Tablet | SCD | 7fc95729-2f5d-4d5c-b26c-3a13854f73e3 | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68382-715-01 | 68382071501 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-01) | 2013-05-16 | 0000-00-00 | No | No | Current | |
| 68382-715-06 | 68382071506 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-06) | 2013-05-16 | 0000-00-00 | No | No | Current | |
| 68382-715-10 | 68382071510 | 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-10) | 2013-05-16 | 0000-00-00 | No | No | Current | |
| 68382-715-16 | 68382071516 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-16) | 2013-05-16 | 0000-00-00 | No | No | Current | |
| 68382-715-30 | 68382071530 | 10 in 1 BLISTER PACK | Historical | |||||
| 68382-715-69 | 68382071569 | 6 in 1 BLISTER PACK | Historical | |||||
| 68382-715-77 | 68382071577 | 10 BLISTER PACK in 1 CARTON (68382-715-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-30) | 10 blister pack | 2013-05-16 | 0000-00-00 | No | No | Current |
| 68382-715-86 | 68382071586 | 1 BLISTER PACK in 1 CARTON (68382-715-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-69) | 1 blister pack | 2013-05-16 | 0000-00-00 | No | No | Current |