zolmitriptan

Product NDC: 45802-711
11-digit product format: 458020711
Labeler code: 45802
Product ID: 45802-711_670da414-66ad-4c5f-b218-f4958daae12c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolmitriptan
Dosage form: SPRAY
Route: NASAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: ANDA212469
Marketing category: ANDA
Marketing start: 2021-11-16
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: 2026-12-31
Current FDA listing: Yes

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
A212469-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30
A212469-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212469-001	AB
A212469-002	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 2 · 66 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	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB	RS	2021-09-30	`6a51e52b5d6a…`

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	A212469-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212469-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212469-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212469-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212469-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212469-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212469-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212469-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212469-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212469-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212469-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212469-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212469-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212469-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212469-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212469-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212469-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212469-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212469-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212469-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212469-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212469-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212469-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212469-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212469-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212469-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212469-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212469-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212469-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212469-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212469-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212469-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212469-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212469-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212469-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212469-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212469-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212469-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212469-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212469-002	AB	1	`6a51e52b5d6a…`

Additional Listing Data#

Finished product: Yes
Brand name base: zolmitriptan
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLMITRIPTAN	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2FS66TH3YW	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
402000	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
24e12658-eb42-4d1f-9192-9c4298416d51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
a0fbe307-6e31-a71d-5232-3216747b9b34	Product name	2	20220316
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
49286735-675f-7ca8-3815-48cfc7bb5a5a	Product name	9	20180828
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-711-00	zolmitriptan	1 in 1 BOTTLE, SPRAY	SPRAY	1		3
45802-711-91	zolmitriptan	6 in 1 CARTON	SPRAY	6		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-711-00	EA - Each	45802-711	892e88be-f46c-414e-8633-c2312a955552	1	2021-11-09
45802-711-91	EA - Each	45802-711	d9a2868f-56f5-4c50-bc18-a261f63db1ec	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-711	ZOLMITRIPTAN SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]	3	Current NDC, Legacy NDC, 2 package rows	20231107_24e12658-eb42-4d1f-9192-9c4298416d51.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	7a6924da-37a0-4e43-b57d-410b5179361b	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212469 application number: ANDA212469
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	e304c986-24fa-451e-a560-0af658ba387b	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212469 application number: ANDA212469
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	8b4e77de-3185-4d1e-946a-96b785b76da0	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212469 application number: ANDA212469
zolmitriptan	ZOLMITRIPTAN	Padagis Israel Pharmaceuticals Ltd	24e12658-eb42-4d1f-9192-9c4298416d51	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212469 application number: ANDA212469 ndc (product): 45802-711

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	8b4e77de-3185-4d1e-946a-96b785b76da0	106
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	8b4e77de-3185-4d1e-946a-96b785b76da0	106
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	8b4e77de-3185-4d1e-946a-96b785b76da0	106
402000	ZOLMitriptan 5 MG/ACTUAT Nasal Spray	PSN	7a6924da-37a0-4e43-b57d-410b5179361b	100
402000	ZOLMitriptan 5 MG/ACTUAT Nasal Spray	PSN	e304c986-24fa-451e-a560-0af658ba387b	100
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	7a6924da-37a0-4e43-b57d-410b5179361b	100
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	e304c986-24fa-451e-a560-0af658ba387b	100
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	7a6924da-37a0-4e43-b57d-410b5179361b	100
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	e304c986-24fa-451e-a560-0af658ba387b	100
402000	ZOLMitriptan 5 MG/ACTUAT Nasal Spray	PSN	24e12658-eb42-4d1f-9192-9c4298416d51	3
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	24e12658-eb42-4d1f-9192-9c4298416d51	3
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	24e12658-eb42-4d1f-9192-9c4298416d51	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-711-00	45802071100	1 in 1 BOTTLE, SPRAY					Historical
45802-711-91	45802071191	6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00)	2021-11-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
zolmitriptan	Bryant Ranch Prepack	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	100
zolmitriptan	Bryant Ranch Prepack	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	100
zolmitriptan	Bryant Ranch Prepack	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	106
zolmitriptan	Padagis Israel Pharmaceuticals Ltd	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	3