Home NDC 83034-003-60 Ohtuvayre
Product NDC 83034-003
Requested package NDC 83034-003-60
11-digit product format 830340003
Labeler code 83034
Product ID 83034-003_6806e1d0-c260-427f-b661-044ca81de168
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 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 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 Product TE source text RLD / RS Approval date Source SHA-256 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 · 53 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 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…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217389-001 9062047 2031-08-21 U-3962 Drug substance 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217389-001 10945950 2035-09-15 Drug product 2024-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217389-001 9956171 2035-09-15 U-3962 Drug product 2024-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217389-001 9062047 2031-08-21 U-3962 Drug substance 2024-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217389-001 10945950 2035-09-15 Drug product 2024-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217389-001 9956171 2035-09-15 U-3962 Drug product 2024-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217389-001 9062047 2031-08-21 U-3962 Drug substance 2024-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217389-001 10945950 2035-09-15 Drug product 2024-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217389-001 9956171 2035-09-15 U-3962 Drug product 2024-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217389-001 9062047 2031-08-21 U-3962 Drug substance 2024-07-12 d8e5a09893c0…
Observed Orange Book exclusivity history# 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.
DailyMed Product Concepts# 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
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83034-003-60 83034000360 60 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE 60 pouch 2024-06-26 No No Current