Home NDC 68462-497 Zolmitriptan
Product NDC 68462-497
11-digit product format 684620497
Labeler code 68462
Product ID 68462-497_742c4c1c-c601-4656-86c1-69021eb552c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc.,USA
Application ANDA201779
Marketing category ANDA
Marketing start 2013-05-14
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 2027-12-31
Current FDA listing Yes 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 A201779-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 A201779-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14
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 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201779-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2013-05-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A201779-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2013-05-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Zolmitriptan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOLMITRIPTAN 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2FS66TH3YW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200193 Internal RxNorm lookup 200194 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-497-40 Zolmitriptan 6 in 1 BLISTER PACK TABLET, FILM COATED 6 14 68462-497-76 Zolmitriptan 1 in 1 CARTON TABLET, FILM COATED 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLMITRIPTAN ACTIVE INGREDIENT 2FS66TH3YW ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-497 ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 13 Current NDC, Legacy NDC, 2 package rows 20240705_333caafc-2e63-49f8-a0c6-534e528d228d.zip
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.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68462-497-40 68462049740 6 in 1 BLISTER PACK Historical 68462-497-76 68462049776 1 BLISTER PACK in 1 CARTON (68462-497-76) / 6 TABLET, FILM COATED in 1 BLISTER PACK (68462-497-40) 1 blister pack 2013-05-14 0000-00-00 No No Current