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United States · US · US:66302-206_78a0b514-481a-4ea9-8ec6-8b60acdf2158
TYVASO
Orange BookUNIISPLATC B01AC21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnited Therapeutics Corporation
CountryUS (United States)
ATC codeB01AC21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1166302206011 BOX in 1 KIT (66302-206-01) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
- ndc1166302206021 BOX in 1 KIT (66302-206-02) / 28 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
- ndc1166302206034 AMPULE in 1 BOX (66302-206-03) / 2.9 mL in 1 AMPULE
- ndc1166302206041 BOX in 1 KIT (66302-206-04) / 4 AMPULE in 1 BOX / 2.9 mL in 1 AMPULE
Annotations
UNII (FDA Substance ID)
RUM6K67ESG
TREPROSTINIL
RxCUI 343048
Orange Book
N022387
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "RUM6K67ESG",
"rxcui": "343048",
"inchikey": "PAJMKGZZBBTTOY-ZFORQUDYSA-N",
"display_name": "TREPROSTINIL",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"cbc31ab1-a80f-4b50-a3b1-39910b0fb609": {
"match": "brand_token",
"title": "TYVASO (TREPROSTINIL) INHALANT [UNITED THERAPEUTICS CORPORATION]",
"spl_version": "32",
"published_date": "2026-04-20"
}
},
"productid": "66302-206_78a0b514-481a-4ea9-8ec6-8b60acdf2158",
"productndc": "66302-206",
"dosage_form": "INHALANT",
"orange_book": {
"appl_no": "022387",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.6MG/ML",
"product_no": "001",
"approval_date": "Jul 30, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TREPROSTINIL",
"proprietary_name": "TYVASO",
"active_ingred_unit": "mg/2.9mL",
"application_number": "NDA022387",
"marketing_category": "NDA",
"nonproprietary_name": "treprostinil",
"start_marketing_date": "20090814",
"active_numerator_strength": "1.74"
}Related drugs
Other records sharing ATC code B01AC21.
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