ZOMIG

Product NDC
64896-681
Requested package NDC
64896-681-51
11-digit product format
648960681
Labeler code
64896
Product ID
64896-681_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
2012-07-02
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage64896-68164896-681-51DDiscontinued by firm2026-08-03

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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64896-681-51EA - Each64896-681b87901be-5c76-4332-a06e-1a25d44a070d12012-07-24

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64896-681-51648960681516 BOTTLE, SPRAY in 1 CARTON (64896-681-51) > 1 SPRAY, METERED in 1 BOTTLE, SPRAY2012-07-020000-00-00NoNoCurrent