Home NDC 64896-671 ZOMIG
Product NDC 64896-671
11-digit product format 648960671
Labeler code 64896
Product ID 64896-671_f5787ecd-e8c4-49b3-9b47-710c31010965
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals
Application NDA020768
Marketing category NDA
Marketing start 2012-04-02
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 2023-12-31
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 · 36 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date N020768-001 ZOMIG ZOLMITRIPTAN 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-11-25 N020768-002 ZOMIG ZOLMITRIPTAN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-11-25
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UTC 2026-02 N020768-001 ZOMIG 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-11-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020768-002 ZOMIG 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-11-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020768-001 ZOMIG 2.5MG TABLET / ORAL RLD 1997-11-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020768-002 ZOMIG 5MG TABLET / ORAL RLD 1997-11-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020768-001 ZOMIG 2.5MG TABLET / ORAL AB RLD 1997-11-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020768-002 ZOMIG 5MG TABLET / ORAL AB RLD, RS 1997-11-25 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 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 ORANGE INACTIVE INGREDIENT 5EVU04N5QU ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 SODIUM BICARBONATE INACTIVE INGREDIENT 8MDF5V39QO ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7 WATER INACTIVE INGREDIENT 059QF0KO0R ZOMIG (ZOLMITRIPTAN) TABLET ZOMIG ZMT (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [IMPAX LABORATORIES, INC.] 7
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64896-671-49 64896067149 1 BLISTER PACK in 1 CARTON (64896-671-49) > 2 TABLET in 1 BLISTER PACK 1 blister pack 2012-04-02 0000-00-00 No No Current 64896-671-51 64896067151 1 BLISTER PACK in 1 CARTON (64896-671-51) > 6 TABLET in 1 BLISTER PACK 1 blister pack 2012-04-02 0000-00-00 No No Current