Home NDC 33342-113 Zolmitriptan
Product NDC 33342-113
11-digit product format 333420113
Labeler code 33342
Product ID 33342-113_9a9c0250-13c1-6c6a-e053-2995a90aaa0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203772
Marketing category ANDA
Marketing start 2015-09-30
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 60 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203772-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 A203772-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30
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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table 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 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203772-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2015-09-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203772-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2015-09-30 782e0a99824c…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLMITRIPTAN ACTIVE INGREDIENT 2FS66TH3YW ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLMITRIPTAN TABLET, FILM COATED ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED] 2