Home NDC 31722-458 ZOLMITRIPTAN
Product NDC 31722-458
11-digit product format 317220458
Labeler code 31722
Product ID 31722-458_117e0844-95dd-4d5c-88b5-e02a2a3a3125
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ZOLMITRIPTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals Inc
Application ANDA204284
Marketing category ANDA
Marketing start 2015-01-05
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 E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 31722-458-06 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 31722-458-06 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 31722-458-06 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 31722-458-06 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 31722-458-06 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 31722-458-06 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 31722-458-06 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 31722-458-06 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 31722-458-06 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 31722-458-06 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 31722-458-06 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 31722-458-06 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 31722-458-06 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 31722-458-06 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 31722-458-06 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 31722-458-06 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 31722-458-06 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 31722-458-06 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 31722-458-06 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 31722-458-06 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 31722-458-06 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 31722-458-06 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A204284-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 A204284-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09
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 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL 2014-04-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL 2014-04-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204284-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2014-04-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204284-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2014-04-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 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 TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 HYPROMELLOSE 2910 (10000 MPA.S) INACTIVE INGREDIENT 0HO1H52958 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 POLYETHYLENE GLYCOL 1000 INACTIVE INGREDIENT U076Q6Q621 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-458 ZOLMITRIPTAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS INC] 2 Legacy NDC 20150121_ac89615d-7618-4c7c-8d4e-1bc74b1f7141.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 · 1 matching rows.