Zolmitriptan OD

Product NDC: 42291-999
11-digit product format: 422910999
Labeler code: 42291
Product ID: 42291-999_3f005170-5c59-50ff-e063-6294a90acefc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolmitriptan
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: AvKARE
Application: ANDA202956
Marketing category: ANDA
Marketing start: 2025-09-17
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
A202956-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-09-17
A202956-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2015-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202956-001	AB
A202956-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202956-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202956-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2015-09-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202956-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202956-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202956-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202956-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202956-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202956-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202956-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202956-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202956-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202956-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202956-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202956-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202956-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202956-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202956-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202956-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202956-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202956-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202956-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202956-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202956-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202956-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202956-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202956-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202956-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202956-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202956-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202956-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202956-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202956-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202956-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202956-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202956-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202956-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202956-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202956-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202956-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202956-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202956-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202956-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zolmitriptan OD
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
284201	Internal RxNorm lookup
351134	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
3f0040a6-b1d6-3d73-e063-6294a90af23c	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
49286735-675f-7ca8-3815-48cfc7bb5a5a	Product name	9	20180828
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-999-03	Zolmitriptan OD	1 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	1		1
42291-999-03	Zolmitriptan OD	3 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	3		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-999-03	EA - Each	42291-999	1f597906-65c4-4676-864f-b73eb66e6fcc	1	2025-10-14

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolmitriptan OD	ZOLMITRIPTAN	Jubilant Cadista Pharmacuticals Inc.	a6a32fc6-4243-9cdd-91c7-b8a58e0f9811	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202956 application number: ANDA202956
Zolmitriptan OD	ZOLMITRIPTAN	AvKARE	3f0040a6-b1d6-3d73-e063-6294a90af23c	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202956 application number: ANDA202956 ndc (product): 42291-999

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
284201	ZOLMitriptan 2.5 MG Disintegrating Oral Tablet	PSN	3f0040a6-b1d6-3d73-e063-6294a90af23c	1
351134	ZOLMitriptan 5 MG Disintegrating Oral Tablet	PSN	3f0040a6-b1d6-3d73-e063-6294a90af23c	1
284201	zolmitriptan 2.5 MG Disintegrating Oral Tablet	SCD	3f0040a6-b1d6-3d73-e063-6294a90af23c	1
351134	zolmitriptan 5 MG Disintegrating Oral Tablet	SCD	3f0040a6-b1d6-3d73-e063-6294a90af23c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-999-03	42291099903	1 BLISTER PACK in 1 CARTON (42291-999-03) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	1 blister pack	2025-09-17	No	No	Current