Zolmitriptan

Product NDC: 46708-181
11-digit product format: 467080181
Labeler code: 46708
Product ID: 46708-181_052016e5-acea-4d2a-8d76-cef36eb99262
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolmitriptan
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA205074
Marketing category: ANDA
Marketing start: 2016-12-01
Substance: ZOLMITRIPTAN
Active strength: 2.5 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
A205074-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2016-12-01
A205074-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2016-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205074-001	AB
A205074-002	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	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205074-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205074-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2016-12-01	`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	A205074-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205074-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205074-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205074-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205074-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205074-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205074-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205074-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205074-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205074-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205074-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205074-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205074-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205074-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205074-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205074-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205074-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205074-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205074-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205074-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205074-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205074-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205074-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205074-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205074-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205074-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205074-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205074-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205074-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205074-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205074-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205074-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205074-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205074-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205074-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205074-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205074-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205074-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205074-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205074-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZOLMITRIPTAN	2.5 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
b8d657ac-dbda-4455-8bb5-3896951c3b67	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46708-181-16	2023-02-01	C162847	48780-1	f386c649-cd26-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS. ZOLMITRIPTAN orally disintegrating tablets Initial U.S. Approval: 1997
46708-181-16	2023-01-30	C162847	48780-1	f386c649-cd26-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS. ZOLMITRIPTAN orally disintegrating tablets Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-181-06	Zolmitriptan	6 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	6		4
46708-181-06	Zolmitriptan	6 in 1 BLISTER PACK	TABLET, ORALLY DISINTEGRATING	6		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-181	ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED]	4	Current NDC, Legacy NDC, 2 package rows	20240224_b8d657ac-dbda-4455-8bb5-3896951c3b67.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Limited	b8d657ac-dbda-4455-8bb5-3896951c3b67	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205074 application number: ANDA205074 ndc (product): 46708-181
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Inc.	89bfee8d-1ddf-4fb2-a565-ce32f096a25d	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205074 application number: ANDA205074

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	b8d657ac-dbda-4455-8bb5-3896951c3b67	4
351134	ZOLMitriptan 5 MG Disintegrating Oral Tablet	PSN	b8d657ac-dbda-4455-8bb5-3896951c3b67	4
284201	zolmitriptan 2.5 MG Disintegrating Oral Tablet	SCD	b8d657ac-dbda-4455-8bb5-3896951c3b67	4
351134	zolmitriptan 5 MG Disintegrating Oral Tablet	SCD	b8d657ac-dbda-4455-8bb5-3896951c3b67	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-181-06	46708018106	6 BLISTER PACK in 1 CARTON (46708-181-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	6 blister pack	2016-12-01		No	No	Current
46708-181-16	46708018116	6 BLISTER PACK in 1 CARTON (46708-181-16) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	6 blister pack	2016-12-01	0000-00-00	No	No	Current