Ohtuvayre

Product NDC: 83034-003
Requested package NDC: 83034-003-65
11-digit product format: 830340003
Labeler code: 83034
Product ID: 83034-003_7fe646a4-f640-4fa6-847c-262de267bab2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ensifentrine
Dosage form: SUSPENSION
Route: RESPIRATORY (INHALATION)
Labeler: MERCK SHARP & DOHME LLC
Application: NDA217389
Marketing category: NDA
Marketing start: 2024-06-26
Substance: ENSIFENTRINE
Active strength: 3 mg/2.5mL
Pharmacologic classes: Phosphodiesterase 3 Inhibitor [EPC], Phosphodiesterase 3 Inhibitors [MoA], Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
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 45.

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
N217389-001	OHTUVAYRE	ENSIFENTRINE	3MG/2.5ML	SUSPENSION / INHALATION		RLD, RS	2024-06-26

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12
N217389-001	10945950	2035-09-15		Drug product	2024-07-12
N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12
N217389-001	12409180	2043-02-20		Drug product	2025-10-07
N217389-001	12251384	2044-06-25		Drug product	2025-03-26

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217389-001	NCE	2029-06-26

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217389-001	OHTUVAYRE	3MG/2.5ML	SUSPENSION / INHALATION	RLD, RS	2024-06-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-11-14 07:37:17	2026-10	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	12409180	2043-02-20		Drug product	2025-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217389-001	12251384	2044-06-25		Drug product	2025-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217389-001	9062047	2031-08-21	U-3962	Drug substance	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217389-001	10945950	2035-09-15		Drug product	2024-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217389-001	9956171	2035-09-15	U-3962	Drug product	2024-07-12	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-11-14 07:37:17	2026-10	N217389-001	NCE	2029-06-26	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	N217389-001	NCE	2029-06-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217389-001	NCE	2029-06-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217389-001	NCE	2029-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217389-001	NCE	2029-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217389-001	NCE	2029-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217389-001	NCE	2029-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217389-001	NCE	2029-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217389-001	NCE	2029-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217389-001	NCE	2029-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217389-001	NCE	2029-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217389-001	NCE	2029-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217389-001	NCE	2029-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217389-001	NCE	2029-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217389-001	NCE	2029-06-26	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217389-001	NCE	2029-06-26	`a50c72e98297…`

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: Ohtuvayre
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENSIFENTRINE	3 mg/2.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3E3D8T1GIX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2687221	Internal RxNorm lookup
2687226	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
e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dad37825-eb7d-4158-8543-bee5e29cf6ac	Product name	1	20250227

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83034-003-01	ML - Milliliter	83034-003	797b2d01-08ef-4538-86a7-e1718e9e5744	1	2024-08-12
83034-003-60	ML - Milliliter	83034-003	e549adae-853f-491e-b161-444e171e33d3	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83034-003	OHTUVAYRE (ENSIFENTRINE) SUSPENSION [VERONA PHARMA, INC.]	3	Current NDC	20240709_e6433c98-41a0-4f99-8f7f-d0e9db6e3f40.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3E3D8T1GIX	ENSIFENTRINE	1884461-72-6	ENSIFENTRINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2687221	ensifentrine 3 MG in 2.5 ML Inhalation Suspension	PSN	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6
2687226	Ohtuvayre 3 MG in 2.5 ML Inhalation Suspension	PSN	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6
2687226	ensifentrine 1.2 MG/ML Inhalation Suspension [Ohtuvayre]	SBD	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6
2687221	ensifentrine 1.2 MG/ML Inhalation Suspension	SCD	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6
2687221	ensifentrine 3 MG per 2.5 ML Inhalation Suspension	SY	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6
2687226	Ohtuvayre 3 MG per 2.5 ML Inhalation Suspension	SY	e6433c98-41a0-4f99-8f7f-d0e9db6e3f40	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83034-003-65	83034000365	60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE	60 pouch	2024-06-26	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ohtuvayre	MERCK SHARP & DOHME LLC \| HOVIONE FARMACIENCIA, S.A. \| INSTITUTO DE SOLDADURA E QUALIDADE \| The Ritedose Corporation \| Quality Chemical Laboratories	2026-10-13	HUMAN PRESCRIPTION DRUG LABEL	7