Ohtuvayre
- Product NDC
- 83034-003
- 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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3E3D8T1GIX |
| Rxcui | 2687221, 2687226 |
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 |
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 |
| 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 |