zolmitriptan

Product NDC: 71335-2947
Requested package NDC: 71335-2947-1
11-digit product format: 713352947
Labeler code: 71335
Product ID: 71335-2947_f5506f45-88cc-4a41-98d7-bbebccaab536
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zolmitriptan
Dosage form: SPRAY
Route: NASAL
Labeler: Bryant Ranch Prepack
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 43.

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 · 70 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
2026-09-14 22:38:34	2026-08	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212469-001	ZOLMITRIPTAN	2.5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212469-002	ZOLMITRIPTAN	5MG/SPRAY	SPRAY / NASAL	AB		2021-09-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212469-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212469-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212469-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212469-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
7a6924da-37a0-4e43-b57d-410b5179361b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2947-1	zolmitriptan	6 in 1 CARTON	SPRAY	6		100
71335-2947-2	zolmitriptan	1 in 1 BOTTLE, SPRAY	SPRAY	1		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2947-1	EA - Each	71335-2947	2aac1f27-a78a-4ade-ac80-85da7c75581b	1	2026-01-08

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 ndc (package): 71335-2947-1 ndc (product): 71335-2947 ndc11 (package): 71335294701
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

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	7a6924da-37a0-4e43-b57d-410b5179361b	100
402000	zolmitriptan 5 MG/ACTUAT Nasal Spray	SCD	7a6924da-37a0-4e43-b57d-410b5179361b	100
402000	zolmitriptan 5 MG/0.1 ML Nasal Spray	SY	7a6924da-37a0-4e43-b57d-410b5179361b	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2947-1	71335294701	6 BOTTLE, SPRAY in 1 CARTON (71335-2947-1) / 1 SPRAY in 1 BOTTLE, SPRAY (71335-2947-2)	2025-10-28	No	No	Current