Home NDC 64896-682-30 ZOMIG
Product NDC 64896-682
Requested package NDC 64896-682-30
11-digit product format 648960682
Labeler code 64896
Product ID 64896-682_b023615a-7793-41a1-abbc-b89bd120b0d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Zolmitriptan
Dosage form SPRAY, METERED
Route NASAL
Labeler Amneal Pharmaceuticals
Application NDA021450
Marketing category NDA
Marketing start 2013-12-06
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021450-003 ZOMIG ZOLMITRIPTAN 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 N021450-004 ZOMIG ZOLMITRIPTAN 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30
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 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD, RS 2013-09-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL RLD 2013-09-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL RLD, RS 2003-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021450-003 ZOMIG 2.5MG/SPRAY SPRAY / NASAL AB RLD 2013-09-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 ZOMIG 5MG/SPRAY SPRAY / NASAL AB RLD, RS 2003-09-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 60 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 6750237 2020-11-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 7220767 2020-11-28 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-003 6750237*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-003 7220767*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-004 6750237*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021450-004 7220767*PED 2021-05-28 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021450-003 6750237*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-003 7220767*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-004 6750237*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021450-004 7220767*PED 2021-05-28 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 6750237 2020-11-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 7220767 2020-11-28 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 6750237*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021450-004 7220767*PED 2021-05-28 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 6750237*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-003 7220767*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 6750237 2020-11-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 7220767 2020-11-28 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 6750237*PED 2021-05-28 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021450-004 7220767*PED 2021-05-28 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021450-003 6750237 2020-11-28 Drug product 2014-04-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 7220767 2020-11-28 Drug product 2014-04-24 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 6750237*PED 2021-05-28 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021450-003 7220767*PED 2021-05-28 Pediatric extension 3f01610625f2…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZOLMITRIPTAN ACTIVE INGREDIENT 2FS66TH3YW ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11 ZOLMITRIPTAN ACTIVE MOIETY 2FS66TH3YW ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11 NITROGEN INACTIVE INGREDIENT N762921K75 ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [IMPAX LABORATORIES, INC.] 11
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64896-682-30 64896068230 1 BOTTLE, SPRAY in 1 CARTON (64896-682-30) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY 2013-12-06 0000-00-00 No No Current