Home NDC 63548-0101 Zolmitriptan
Product NDC 63548-0101
11-digit product format 635480101
Labeler code 63548
Product ID 63548-0101_bf9467df-5c81-4b04-8ca3-e3f9104132e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application ANDA207867
Marketing category ANDA
Marketing start 2017-02-27
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 2026-12-31
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 A207867-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 A207867-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27
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 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207867-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2017-02-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207867-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2017-02-27 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 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63548-0101-6 Zolmitriptan 6 in 1 BLISTER PACK TABLET, FILM COATED 6 8 63548-0101-6 Zolmitriptan 1 in 1 CARTON TABLET, FILM COATED 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63548-0101 ZOLMITRIPTAN TABLET, FILM COATED [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS] 8 Current NDC, Legacy NDC, 2 package rows 20230210_f59bfbdd-7f4b-4a29-8396-e144dde65878.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 · 3 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 63548-0101-6 63548010106 1 BLISTER PACK in 1 CARTON (63548-0101-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2017-02-27 0000-00-00 No No Current