ZOMIG

Product NDC
64896-084
11-digit product format
648960084
Labeler code
64896
Product ID
64896-084_00c29925-0e82-4be0-b335-efb0e4ffa0fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amneal Pharmaceuticals LLC
Application
NDA021450
Marketing category
NDA
Marketing start
2024-07-15
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64896-084IInactivated by FDA2026-08-03
excluded packagepackage64896-08464896-084-12IInactivated by FDA2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021450-003ZOMIGZOLMITRIPTAN2.5MG/SPRAYSPRAY / NASALABRLD, RS2013-09-16
N021450-004ZOMIGZOLMITRIPTAN5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021450-003AB
N021450-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD, RS2013-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD, RS2013-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD, RS2013-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALRLD2013-09-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-004ZOMIG5MG/SPRAYSPRAY / NASALRLD, RS2003-09-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021450-003ZOMIG2.5MG/SPRAYSPRAY / NASALABRLD2013-09-16782e0a99824c…
2021-12-28 21:50 UTC2021-12N021450-004ZOMIG5MG/SPRAYSPRAY / NASALABRLD, RS2003-09-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021450-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021450-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021450-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021450-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021450-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021450-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021450-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021450-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021450-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021450-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021450-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021450-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021450-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021450-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021450-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021450-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021450-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021450-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021450-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021450-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021450-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021450-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021450-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021450-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021450-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021450-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021450-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021450-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021450-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021450-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021450-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021450-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021450-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021450-004AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N021450-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021450-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021450-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021450-004AB1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021450-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021450-004AB16a51e52b5d6a…

Observed Orange Book patent history#

Patent history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021450-00367502372020-11-28Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-00372207672020-11-28Drug product2014-04-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-0036750237*PED2021-05-28Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-0037220767*PED2021-05-28Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-00467502372020-11-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-00472207672020-11-28Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-0046750237*PED2021-05-28Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021450-0047220767*PED2021-05-28Pediatric extension74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021450-0036750237*PED2021-05-28Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021450-0037220767*PED2021-05-28Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021450-0046750237*PED2021-05-28Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021450-0047220767*PED2021-05-28Pediatric extension782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021450-0036750237*PED2021-05-28Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021450-0037220767*PED2021-05-28Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021450-0046750237*PED2021-05-28Pediatric extension87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021450-0047220767*PED2021-05-28Pediatric extension87673890dc5c…
2021-03-12 10:30 UTC2021-03N021450-0036750237*PED2021-05-28Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021450-0037220767*PED2021-05-28Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021450-0046750237*PED2021-05-28Pediatric extension5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021450-0047220767*PED2021-05-28Pediatric extension5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021450-00367502372020-11-28Drug product2014-04-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-00372207672020-11-28Drug product2014-04-248869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-0036750237*PED2021-05-28Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-0037220767*PED2021-05-28Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-00467502372020-11-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-00472207672020-11-28Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-0046750237*PED2021-05-28Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021450-0047220767*PED2021-05-28Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021450-00367502372020-11-28Drug product2014-04-24c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-00372207672020-11-28Drug product2014-04-24c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-0036750237*PED2021-05-28Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-0037220767*PED2021-05-28Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-00467502372020-11-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-00472207672020-11-28Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-0046750237*PED2021-05-28Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021450-0047220767*PED2021-05-28Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021450-00367502372020-11-28Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N021450-00372207672020-11-28Drug product2014-04-243f01610625f2…
2019-12-14 00:12 UTC2019-12N021450-0036750237*PED2021-05-28Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021450-0037220767*PED2021-05-28Pediatric extension3f01610625f2…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64896-084-12ZOMIG6 in 1 CARTONSPRAY, METERED66
64896-084-12ZOMIG1 in 1 BOTTLE, SPRAYSPRAY, METERED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-084-12EA - Each64896-0844a135e2a-bcc1-4fca-b070-2ec22a59fb4112024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64896-084ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [AMNEAL PHARMACEUTICALS LLC]4Current NDC, 2 package rows20240828_2438c223-605b-4885-afc3-a6794f190f89.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZolmitriptanZOLMITRIPTANAmneal Pharmaceuticals NY LLC05a40502-149d-41bd-966e-771e937a955b2019-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021450
application number: NDA021450

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483677ZOLMitriptan 2.5 MG/ACTUAT Nasal SprayPSN2438c223-605b-4885-afc3-a6794f190f896
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSN2438c223-605b-4885-afc3-a6794f190f896
1483679Zomig 2.5 MG/ACTUAT Nasal SprayPSN2438c223-605b-4885-afc3-a6794f190f896
402169Zomig 5 MG/ACTUAT Nasal SprayPSN2438c223-605b-4885-afc3-a6794f190f896
1483679zolmitriptan 2.5 MG/ACTUAT Nasal Spray [Zomig]SBD2438c223-605b-4885-afc3-a6794f190f896
402169zolmitriptan 5 MG/ACTUAT Nasal Spray [Zomig]SBD2438c223-605b-4885-afc3-a6794f190f896
1483677zolmitriptan 2.5 MG/ACTUAT Nasal SpraySCD2438c223-605b-4885-afc3-a6794f190f896
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCD2438c223-605b-4885-afc3-a6794f190f896
1483677zolmitriptan 2.5 MG/0.1 ML Nasal SpraySY2438c223-605b-4885-afc3-a6794f190f896
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySY2438c223-605b-4885-afc3-a6794f190f896
1483679Zomig 2.5 MG/0.1 ML Nasal SpraySY2438c223-605b-4885-afc3-a6794f190f896
402169Zomig 5 MG/0.1 ML Nasal SpraySY2438c223-605b-4885-afc3-a6794f190f896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64896-084-12648960084126 BOTTLE, SPRAY in 1 CARTON (64896-084-12) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY2024-07-15NoNoHistorical