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United States · US · US:83034-003_6806e1d0-c260-427f-b661-044ca81de168
Ohtuvayre
Orange BookUNIISPLATC R03BX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMERCK SHARP & DOHME LLC
CountryUS (United States)
ATC codeR03BX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11830340036060 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE
- ndc11830340036560 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
3E3D8T1GIX
ENSIFENTRINE
Orange Book
N217389
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3E3D8T1GIX",
"rxcui": null,
"inchikey": "CSOBIBXVIYAXFM-BYNJWEBRSA-N",
"display_name": "ENSIFENTRINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "RESPIRATORY (INHALATION)",
"spl_meta": {
"e6433c98-41a0-4f99-8f7f-d0e9db6e3f40": {
"match": "brand_token",
"title": "OHTUVAYRE (ENSIFENTRINE) SUSPENSION [ MERCK SHARP & DOHME LLC]",
"spl_version": "6",
"published_date": "2026-05-04"
}
},
"productid": "83034-003_6806e1d0-c260-427f-b661-044ca81de168",
"productndc": "83034-003",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "217389",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "3MG/2.5ML",
"product_no": "001",
"approval_date": "Jun 26, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ENSIFENTRINE",
"proprietary_name": "Ohtuvayre",
"active_ingred_unit": "mg/2.5mL",
"application_number": "NDA217389",
"marketing_category": "NDA",
"nonproprietary_name": "ensifentrine",
"start_marketing_date": "20240626",
"active_numerator_strength": "3"
}Related drugs
Other records sharing ATC code R03BX.
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