Sumavel DosePro

Product NDC: 43376-104
11-digit product format: 433760104
Labeler code: 43376
Product ID: 43376-104_5c36c308-b26d-492d-b923-80f600727c8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan
Dosage form: INJECTION
Route: SUBCUTANEOUS
Labeler: Zogenix, Inc.
Application: NDA022239
Marketing category: NDA
Marketing start: 2013-12-04
Marketing end: 0000-00-00
Substance: SUMATRIPTAN SUCCINATE
Active strength: 4 mg/.5mL
Pharmacologic classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43376-104		I	Inactivated by FDA	2026-08-17
excluded package	package	43376-104	43376-104-01	I	Inactivated by FDA	2026-08-17
excluded package	package	43376-104	43376-104-06	I	Inactivated by FDA	2026-08-17
excluded package	package	43376-104	43376-104-51	I	Inactivated by FDA	2026-08-17
excluded package	package	43376-104	43376-104-54	I	Inactivated by FDA	2026-08-17

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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43376-104-54	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43376-104-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43376-104-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43376-104-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43376-104-54	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43376-104-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43376-104-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43376-104-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43376-104-54	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43376-104-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43376-104-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43376-104-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43376-104-54	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43376-104-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43376-104-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43376-104-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43376-104-54	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43376-104-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43376-104-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43376-104-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43376-104-54	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43376-104-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43376-104-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43376-104-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43376-104-54	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43376-104-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43376-104-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43376-104-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43376-104-54	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43376-104-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43376-104-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43376-104-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43376-104-54	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43376-104-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43376-104-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43376-104-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43376-104-54	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43376-104-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43376-104-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43376-104-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43376-104-54	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43376-104-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43376-104-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43376-104-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43376-104-54	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43376-104-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43376-104-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43376-104-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022239-001	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2009-07-15
N022239-002	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS		RLD	2013-11-26

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022239-001	7901385	2026-07-31		Drug product	2011-03-23
N022239-001	7776007	2026-11-22		Drug product	2011-03-04

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022239-001	SUMAVEL DOSEPRO	EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2009-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022239-002	SUMAVEL DOSEPRO	EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)	INJECTABLE / SUBCUTANEOUS	RLD	2013-11-26	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 245 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022239-001	8287489	2024-12-06	Drug product	2012-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022239-001	7901385	2026-07-31	Drug product	2011-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022239-001	7776007	2026-11-22	Drug product	2011-03-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022239-001	8343130	2022-10-18	Drug product	2013-01-25	`5c6f7cd8ea54…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2	Product name	4	20250724
2839c963-7eb3-970a-287f-ff1b6d381268	Product name	2	20250103
1e973b2d-e028-69cd-9258-4613ba80fdc5	Product name	3	20210512
3eb481d3-8b69-436f-82dd-4a66345568ab	Product name	1	20190611
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877c	Product name	1	20160303
49615343-b619-4365-8118-8f2ed6046e78	Product name	1	20160224
a6319377-430a-43db-82f9-30d1d9d89cf8	Product name	1	20151216
f6199b09-e585-7ceb-4b09-803cf5ce1ed1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43376-104-01	These highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-104-06	These highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-104-51	These highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-104-54	These highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43376-104-01	Sumavel DosePro	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5	13
43376-104-01	Sumavel DosePro	1 in 1 CARTON	INJECTION	1	13
43376-104-06	Sumavel DosePro	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5	13
43376-104-06	Sumavel DosePro	6 in 1 CARTON	INJECTION	6	13
43376-104-51	Sumavel DosePro	1 in 1 CARTON	INJECTION	1	13
43376-104-51	Sumavel DosePro	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5	13
43376-104-54	Sumavel DosePro	0.5 mL in 1 SYRINGE, GLASS	INJECTION	0.5	13
43376-104-54	Sumavel DosePro	4 in 1 CARTON	INJECTION	4	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43376-104-06	ML - Milliliter	43376-104	38fe0435-80ac-4f1b-8180-30ae96514b29	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SUMATRIPTAN SUCCINATE	ACTIVE INGREDIENT	J8BDZ68989	SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]	13
SUMATRIPTAN	ACTIVE MOIETY	8R78F6L9VO	SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]	13
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43376-104	SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]	13	Legacy NDC, 8 package rows	20140212_6a4c0c2f-497d-4c5c-84c4-9ab42780cbde.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE
8R78F6L9VO	SUMATRIPTAN	103628-46-2	sumatriptan

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1657178	SUMAtriptan 4 MG in 0.5 ML Jet Injector	PSN	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657167	SUMAtriptan 6 MG in 0.5 ML Jet Injector	PSN	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	Sumavel 4 MG in 0.5 ML Jet Injector	PSN	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	Sumavel 6 MG in 0.5 ML Jet Injector	PSN	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	0.5 ML sumatriptan 12 MG/ML Jet Injector [Sumavel]	SBD	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	0.5 ML sumatriptan 8 MG/ML Jet Injector [Sumavel]	SBD	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657167	0.5 ML sumatriptan 12 MG/ML Jet Injector	SCD	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657178	0.5 ML sumatriptan 8 MG/ML Jet Injector	SCD	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	0.5 ML Sumavel 12 MG/ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	0.5 ML Sumavel 8 MG/ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657178	sumatriptan (as sumatriptan succinate) 4 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657167	sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657178	sumatriptan 4 MG per 0.5 ML Needle-Free Drug Delivery System	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657167	sumatriptan 6 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1657167	sumatriptan 6 MG per 0.5 ML Needle-Free Drug Delivery System	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	Sumavel (as sumatriptan succinate) 4 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	Sumavel (as sumatriptan succinate) 6 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	Sumavel 4 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	Sumavel 6 MG per 0.5 ML Jet Injector	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
1484927	Sumavel DosePro 4 MG per 0.5 ML Needle-Free Drug Delivery System	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13
856789	Sumavel DosePro 6 MG per 0.5 ML Needle-Free Drug Delivery System	SY	6a4c0c2f-497d-4c5c-84c4-9ab42780cbde	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
43376-104-01	43376010401	0.5 mL in 1 SYRINGE, GLASS	0.5 ml	Historical
43376-104-06	43376010406	0.5 mL in 1 SYRINGE, GLASS	0.5 ml	Historical
43376-104-51	43376010451	1 in 1 CARTON		Historical
43376-104-54	43376010454	0.5 mL in 1 SYRINGE, GLASS	0.5 ml	Historical