Dsuvia

Product NDC: 61621-430
11-digit product format: 616210430
Labeler code: 61621
Product ID: 61621-430_96954bac-d035-4abc-b2cc-03c54a1459f7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sufentanil
Dosage form: TABLET
Route: SUBLINGUAL
Labeler: AcelRx Pharmaceuticals, Inc.
Application: NDA209128
Marketing category: NDA
Marketing start: 2018-11-02
Marketing end: 2026-07-31
Substance: SUFENTANIL
Active strength: 30 ug/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61621-430		D	Discontinued by firm	2026-09-14
excluded package	package	61621-430	61621-430-01	D	Discontinued by firm	2026-09-14
excluded package	package	61621-430	61621-430-11	D	Discontinued by firm	2026-09-14

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209128-001	DSUVIA	SUFENTANIL CITRATE	EQ 0.03MG BASE	TABLET / SUBLINGUAL		RLD	2018-11-02

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19
N209128-001	10342762	2027-01-05		Drug product	2019-07-23
N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09
N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28
N209128-001	8231900	2027-01-05		Drug product	2018-11-28
N209128-001	8252328	2027-01-05		Drug product	2018-11-28
N209128-001	8252329	2027-01-05		Drug product	2018-11-28
N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28
N209128-001	8778393	2027-01-05	U-1351		2018-11-28
N209128-001	8778394	2027-01-05	U-1351		2018-11-28
N209128-001	8865211	2027-01-05	U-1351		2018-11-28
N209128-001	9320710	2027-01-05	U-1351		2018-11-28
N209128-001	9744129	2027-01-05		Drug product	2018-11-28
N209128-001	10896751	2030-03-16		Drug product	2021-02-02
N209128-001	11676691	2030-03-16		Drug product	2023-07-13
N209128-001	12033733	2030-03-16		Drug product	2024-07-31
N209128-001	8574189	2030-03-16		Drug product	2018-11-28
N209128-001	8202535	2030-10-22	U-1351		2018-11-28
N209128-001	8865743	2030-10-22	U-1351		2018-11-28
N209128-001	8945592	2031-07-29		Drug product	2018-11-28
N209128-001	11672738	2038-02-02		Drug product	2023-07-13

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD	2018-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209128-001	DSUVIA	EQ 0.03MG BASE	TABLET / SUBLINGUAL	RLD, RS	2018-11-02	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 21 · 821 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10342762	2027-01-05		Drug product	2019-07-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8231900	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8252328	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8252329	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8778393	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8778394	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8865211	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	9320710	2027-01-05	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	9744129	2027-01-05		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	10896751	2030-03-16		Drug product	2021-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	11676691	2030-03-16		Drug product	2023-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	12033733	2030-03-16		Drug product	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8574189	2030-03-16		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8202535	2030-10-22	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8865743	2030-10-22	U-1351		2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	8945592	2031-07-29		Drug product	2018-11-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209128-001	11672738	2038-02-02		Drug product	2023-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209128-001	10245228	2027-01-05	U-1351	Drug product	2019-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10342762	2027-01-05		Drug product	2019-07-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10507180	2027-01-05	U-1351	Drug product	2020-01-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8226978	2027-01-05	U-1351	Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8231900	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8252328	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8252329	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8535714	2027-01-05	U-1351	Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8778393	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8778394	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8865211	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	9320710	2027-01-05	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	9744129	2027-01-05		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	10896751	2030-03-16		Drug product	2021-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	11676691	2030-03-16		Drug product	2023-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	12033733	2030-03-16		Drug product	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8574189	2030-03-16		Drug product	2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8202535	2030-10-22	U-1351		2018-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209128-001	8865743	2030-10-22	U-1351		2018-11-28	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N209128-001	NP	2021-11-02	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209128-001	NP	2021-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209128-001	NP	2021-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209128-001	NP	2021-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209128-001	NP	2021-11-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209128-001	NP	2021-11-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209128-001	NP	2021-11-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209128-001	NP	2021-11-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209128-001	NP	2021-11-02	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9b3e2158-450c-4453-8e1f-6c2599ad44e8	Product name	2	20190326
32fdfb19-84e5-ae72-0ab9-a69524b6463f	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61621-430-01	Dsuvia	1 in 1 POUCH	TABLET	1		8
61621-430-11	Dsuvia	10 in 1 CARTON	TABLET	10		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61621-430-01	EA - Each	61621-430	4be9d937-8827-46e6-bfeb-e9f31681efe5	1	2019-02-13
61621-430-11	EA - Each	61621-430	23f7c3fa-ae99-497d-8c36-a73b91bce650	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61621-430	DSUVIA (SUFENTANIL) TABLET [ACELRX PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20231222_8b580f3d-e3b5-4086-b093-87a980631147.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
AFE2YW0IIZ	SUFENTANIL	56030-54-7	SUFENTANIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2103199	DSUVIA 30 MCG Sublingual Tablet	PSN	8b580f3d-e3b5-4086-b093-87a980631147	8
2103192	SUFentanil 30 MCG Sublingual Tablet	PSN	8b580f3d-e3b5-4086-b093-87a980631147	8
2103199	sufentanil 0.03 MG Sublingual Tablet [Dsuvia]	SBD	8b580f3d-e3b5-4086-b093-87a980631147	8
2103192	sufentanil 0.03 MG Sublingual Tablet	SCD	8b580f3d-e3b5-4086-b093-87a980631147	8
2103199	Dsuvia 0.03 MG Sublingual Tablet	SY	8b580f3d-e3b5-4086-b093-87a980631147	8
2103199	Dsuvia 30 MCG Sublingual Tablet	SY	8b580f3d-e3b5-4086-b093-87a980631147	8
2103192	sufentanil 30 MCG Sublingual Tablet	SY	8b580f3d-e3b5-4086-b093-87a980631147	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61621-430-01	61621043001	1 TABLET in 1 POUCH (61621-430-01)	1 tablet	2018-11-02	2026-07-31	No	No	Current
61621-430-11	61621043011	10 TABLET in 1 CARTON (61621-430-11)	10 tablet	2018-11-02	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dsuvia	AcelRx Pharmaceuticals, Inc. \| Patheon Pharmaceuticals Inc.	2025-12-30	HUMAN PRESCRIPTION DRUG LABEL	8