Home NDC 59746-433 Zolmitriptan
Product NDC 59746-433
11-digit product format 597460433
Labeler code 59746
Product ID 59746-433_9f9ec6cf-1562-41a9-9219-7b993eeb175c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA202279
Marketing category ANDA
Marketing start 2014-11-20
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 2022-12-31
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 2 · 75 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 A202279-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 A202279-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202279-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202279-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-11-20 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 59746-433-13 2026-01-05 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-15 2026-01-05 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-16 2026-01-05 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-17 2026-01-05 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-13 2023-01-30 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-15 2023-01-30 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-16 2023-01-30 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997 59746-433-17 2023-01-30 These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLMITRIPTAN ACTIVE INGREDIENT 2FS66TH3YW ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Anhydrous Lactose INACTIVE INGREDIENT 3SY5LH9PMK ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Polyethylene Glycol 400 INACTIVE INGREDIENT B697894SGQ ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Polyethylene Glycol 8000 INACTIVE INGREDIENT Q662QK8M3B ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-433 ZOLMITRIPTAN (ZOLMITRIPTAN) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 6 Legacy NDC 20210116_8b4fe798-ccbd-e0cc-d219-5a70d8115f43.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59746-433-13 59746043313 1 BLISTER PACK in 1 CARTON (59746-433-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-433-04) 1 blister pack 2014-11-20 0000-00-00 No No Current 59746-433-15 59746043315 1 BLISTER PACK in 1 CARTON (59746-433-15) > 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2014-11-20 0000-00-00 No No Current 59746-433-16 59746043316 2 BLISTER PACK in 1 CARTON (59746-433-16) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-433-04) 2 blister pack 2014-12-20 0000-00-00 No No Current 59746-433-17 59746043317 2 BLISTER PACK in 1 CARTON (59746-433-17) > 3 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2014-11-20 0000-00-00 No No Current