Home NDC 68382-712 Zolmitriptan
Product NDC 68382-712
11-digit product format 683820712
Labeler code 68382
Product ID 68382-712_69253ff3-21fa-46de-8f27-668eb8aa6e94
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA203019
Marketing category ANDA
Marketing start 2018-11-12
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68382-712-86 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68382-712-86 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A203019-001 ZOLMITRIPTAN ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 A203019-002 ZOLMITRIPTAN ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11
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 · 88 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 2026-10-15 13:18:30 2026-09 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203019-001 ZOLMITRIPTAN 2.5MG TABLET / ORAL AB 2018-07-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203019-002 ZOLMITRIPTAN 5MG TABLET / ORAL AB 2018-07-11 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-712 ZOLMITRIPTAN TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 3 Legacy NDC 20221115_5cdb0f27-ff96-4636-9d72-dc985826cccb.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68382-712-86 68382071286 1 BLISTER PACK in 1 CARTON (68382-712-86) > 6 TABLET, FILM COATED in 1 BLISTER PACK (68382-712-69) 1 blister pack 2018-11-12 0000-00-00 No No Current