naratriptan

Product NDC: 87063-288
Requested package NDC: 87063-288-09
11-digit product format: 870630288
Labeler code: 87063
Product ID: 87063-288_586e484f-099e-4e71-e063-6294a90af7d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naratriptan
Dosage form: TABLET
Route: ORAL
Labeler: ASCLEMED USA INC.
Application: ANDA200502
Marketing category: ANDA
Marketing start: 2011-03-15
Substance: NARATRIPTAN HYDROCHLORIDE
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: 2027-12-31
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
A200502-001	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28
A200502-002	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200502-001	AB
A200502-002	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 · 86 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	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	RS	2011-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB		2011-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB		2011-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB		2011-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200502-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB		2011-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200502-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB		2011-02-28	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A200502-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200502-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200502-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200502-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200502-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200502-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200502-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200502-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200502-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200502-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200502-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200502-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200502-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200502-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200502-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200502-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200502-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200502-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200502-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200502-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200502-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200502-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200502-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200502-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200502-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200502-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200502-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200502-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200502-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200502-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200502-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200502-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200502-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200502-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200502-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200502-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200502-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200502-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200502-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200502-002	AB	1	`74a2ff9319b5…`

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: naratriptan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NARATRIPTAN HYDROCHLORIDE	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
10X8X4P12Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311918	Internal RxNorm lookup
314135	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
63ea356f-0895-4540-b242-8e611eacd938	Available on FDA.report

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
naratriptan	NARATRIPTAN	ASCLEMED USA INC.	63ea356f-0895-4540-b242-8e611eacd938	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200502 application number: ANDA200502 ndc (package): 87063-288-09 ndc (product): 87063-288 ndc11 (package): 87063028809
naratriptan	NARATRIPTAN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	41c29652-32f8-48dc-9038-0e2195aa2084	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200502 application number: ANDA200502

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10X8X4P12Z	NARATRIPTAN HYDROCHLORIDE	143388-64-1	NARATRIPTAN HYDROCHLORIDE
QX3KXL1ZA2	NARATRIPTAN	121679-13-8	naratriptan

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87063-288-09	87063028809	9 TABLET in 1 BLISTER PACK (87063-288-09)	9 tablet	2026-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
naratriptan	ASCLEMED USA INC. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-08-07	HUMAN PRESCRIPTION DRUG LABEL	1