Zolmitriptan

Product NDC: 64980-256
Requested package NDC: 64980-256-16
11-digit product format: 649800256
Labeler code: 64980
Product ID: 64980-256_4f9b78fd-a87e-4fbd-ad5f-75ea878ba35f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Zolmitriptan
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Rising Pharmaceuticals, Inc.
Application: ANDA205074
Marketing category: ANDA
Marketing start: 2017-04-13
Marketing end: 0000-00-00
Substance: ZOLMITRIPTAN
Active strength: 3 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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64980-256	64980-256-16	D	Discontinued by firm		2026-08-07

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-256-16	EA - Each	64980-256	6c1165ad-5019-4158-9bb6-6372911be434	1	2017-07-07

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-256-16	64980025616	6 BLISTER PACK in 1 CARTON (64980-256-16) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	6 blister pack	2017-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zolmitriptan	Rising Pharmaceuticals, Inc. \| Alembic Pharmaceuticals Limited	2019-04-09	Human Prescription Drug Label	4