ZOMIG

Product NDC: 21695-955
11-digit product format: 216950955
Labeler code: 21695
Product ID: 21695-955_f2073122-5138-41ba-b791-a9b088bb98b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolmitriptan
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Rebel Distributors Corp
Application: NDA021450
Marketing category: NDA
Marketing start: 2010-06-08
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: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-955		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-955	21695-955-06	I	Inactivated by FDA		2026-08-03

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 · 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	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	21695-955-06	`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	21695-955-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-955-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-955-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-955-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-955-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-955-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-955-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-955-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-955-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-955-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-955-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-955-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-955-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-955-06	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-955-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-955-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-955-06	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-955-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-955-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-955-06	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-955-06	`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
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.

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

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021450-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021450-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021450-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021450-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021450-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021450-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021450-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021450-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021450-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021450-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021450-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021450-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021450-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021450-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021450-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021450-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021450-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021450-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021450-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021450-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021450-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021450-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021450-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021450-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021450-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021450-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021450-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021450-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021450-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021450-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021450-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021450-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021450-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021450-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021450-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021450-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021450-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021450-004	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021450-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021450-004	AB	1	`6a51e52b5d6a…`

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	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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a0fbe307-6e31-a71d-5232-3216747b9b34	Product name	2	20220316
49286735-675f-7ca8-3815-48cfc7bb5a5a	Product name	9	20180828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-955-06	2019-09-24	C162847	48780-1	934fe258-48fc-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ZOMIG NASAL SPRAY. See full prescribing information for ZOMIG ® (zolmitriptan) NASAL SPRAY INITIAL U.S. APPROVAL: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-955-06	ZOMIG	1 in 1 BOTTLE, SPRAY	SPRAY, METERED	1		1
21695-955-06	ZOMIG	6 in 1 CARTON	SPRAY, METERED	6		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-955-06	EA - Each	21695-955	70df7738-110b-4fb0-ba90-c2f5d44413ac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZOLMITRIPTAN	ACTIVE INGREDIENT	2FS66TH3YW	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
ZOLMITRIPTAN	ACTIVE MOIETY	2FS66TH3YW	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
CITRIC ACID ANHYDROUS	INACTIVE INGREDIENT	XF417D3PSL	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
NITROGEN	INACTIVE INGREDIENT	N762921K75	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-955	ZOMIG (ZOLMITRIPTAN) SPRAY, METERED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20110914_f2073122-5138-41ba-b791-a9b088bb98b7.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolmitriptan	ZOLMITRIPTAN	Amneal Pharmaceuticals NY LLC	05a40502-149d-41bd-966e-771e937a955b	2019-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021450 application number: NDA021450

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2FS66TH3YW	ZOLMITRIPTAN	139264-17-8	ZOLMITRIPTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402000	ZOLMitriptan 5 MG/ACTUAT Nasal Spray	PSN	f2073122-5138-41ba-b791-a9b088bb98b7	1
402169	Zomig 5 MG/ACTUAT Nasal Spray	PSN	f2073122-5138-41ba-b791-a9b088bb98b7	1
402169	zolmitriptan 5 MG/ACTUAT Nasal Spray [Zomig]	SBD	f2073122-5138-41ba-b791-a9b088bb98b7	1
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	f2073122-5138-41ba-b791-a9b088bb98b7	1
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	f2073122-5138-41ba-b791-a9b088bb98b7	1
402169	Zomig 5 MG/0.1 ML Nasal Spray	SY	f2073122-5138-41ba-b791-a9b088bb98b7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-955-06	21695095506	1 in 1 BOTTLE, SPRAY	Historical