Home NDC 59746-432 Zolmitriptan
Product NDC 59746-432
11-digit product format 597460432
Labeler code 59746
Product ID 59746-432_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 3 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 1 · 45 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# 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 59746-432 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 59746-432-13 59746043213 1 BLISTER PACK in 1 CARTON (59746-432-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-432-04) 1 blister pack 2014-11-21 0000-00-00 No No Current 59746-432-16 59746043216 2 BLISTER PACK in 1 CARTON (59746-432-16) > 3 TABLET, FILM COATED in 1 BLISTER PACK (59746-432-04) 2 blister pack 2014-11-20 0000-00-00 No No Current