Home NDC 16571-804 Zolmitriptan
Product NDC 16571-804
11-digit product format 165710804
Labeler code 16571
Product ID 16571-804_fcf22883-8cbb-4185-99ba-5be1bcfb9306
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207021
Marketing category ANDA
Marketing start 2016-05-11
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 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 A207021-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 A207021-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11
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 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207021-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2016-05-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A207021-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2016-05-11 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 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 16571-804-13 Zolmitriptan 1 in 1 CARTON TABLET, FILM COATED 1 3 16571-804-13 Zolmitriptan 3 in 1 BLISTER PACK TABLET, FILM COATED 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-804 ZOLMITRIPTAN TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240301_5fcdc5d6-38fa-458d-a581-4e3678a9e8fd.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 16571-804-13 16571080413 1 BLISTER PACK in 1 CARTON (16571-804-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2016-05-11 0000-00-00 No No Current