Tyvaso DPI

Product NDC: 66302-640
11-digit product format: 663020640
Labeler code: 66302
Product ID: 66302-640_81912284-3d3a-430e-a55e-df239b084535
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: treprostinil
Dosage form: KIT
Labeler: United Therapeutics Corporation
Application: NDA214324
Marketing category: NDA
Marketing start: 2023-06-27
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214324-001	TYVASO DPI	TREPROSTINIL	0.016MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-002	TYVASO DPI	TREPROSTINIL	0.032MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-003	TYVASO DPI	TREPROSTINIL	0.048MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-004	TYVASO DPI	TREPROSTINIL	0.064MG/INH	POWDER / INHALATION	RLD, RS	2022-05-23
N214324-005	TYVASO DPI	TREPROSTINIL	0.08MG/INH	POWDER / INHALATION	RLD, RS	2024-10-24

Orange Book patents#

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214324-001	11357782	2027-05-14	U-1849		2025-04-24
N214324-001	11723887	2028-12-15		Drug substance	2023-08-15
N214324-001	9593066	2028-12-15		Drug substance	2022-06-17
N214324-001	10772883	2030-06-11		Drug product	2022-06-17
N214324-001	10421729	2035-04-01		Drug product	2022-06-17
N214324-001	11826327	2042-02-03	U-3749		2023-11-28
N214324-002	11357782	2027-05-14	U-1849		2025-04-24
N214324-002	11723887	2028-12-15		Drug substance	2023-08-15
N214324-002	9593066	2028-12-15		Drug substance	2022-06-17
N214324-002	10772883	2030-06-11		Drug product	2022-06-17
N214324-002	10421729	2035-04-01		Drug product	2022-06-17
N214324-002	11826327	2042-02-03	U-3749		2023-11-28
N214324-003	11357782	2027-05-14	U-1849		2025-04-24
N214324-003	11723887	2028-12-15		Drug substance	2023-08-15
N214324-003	9593066	2028-12-15		Drug substance	2022-06-17
N214324-003	10772883	2030-06-11		Drug product	2022-06-17
N214324-003	10421729	2035-04-01		Drug product	2022-06-17
N214324-003	11826327	2042-02-03	U-3749		2023-11-28
N214324-004	11357782	2027-05-14	U-1849		2025-04-24
N214324-004	11723887	2028-12-15		Drug substance	2023-08-15
N214324-004	9593066	2028-12-15		Drug substance	2022-06-17
N214324-004	10772883	2030-06-11		Drug product	2022-06-17
N214324-004	10421729	2035-04-01		Drug product	2022-06-17
N214324-004	11826327	2042-02-03	U-3749		2023-11-28
N214324-005	11357782	2027-05-14	U-1849		2025-04-24
N214324-005	11723887	2028-12-15		Drug substance	2024-11-18
N214324-005	9593066	2028-12-15		Drug substance	2024-11-18
N214324-005	10772883	2030-06-11		Drug product	2024-11-18
N214324-005	10421729	2035-04-01		Drug product	2024-11-18
N214324-005	11826327	2042-02-03	U-3749		2024-11-18

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tyvaso DPI	TREPROSTINIL	United Therapeutics Corporation	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	2025-11-20	Warnings, Adverse reactions	Exact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Tyvaso DPI may cause symptomatic hypotension. ( 5.1 ) Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) Tyvaso DPI dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.3 ) May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 ) 5.1 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with Tyvaso DPI may produce symptomatic hypotension. 5.2 Risk of Bleeding Tyvaso DPI inhibits platelet aggregation and increases the risk of bleeding. 5.3 Effect of Other Drugs on Treprostinil Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . 5.4 Bronchospasm Like other inhaled prostaglandins, Tyvaso DPI may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with Tyvaso DPI.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions (5): - Decrease in systemic blood pressure [see Warnings and Precautions (5.1) ] . - Bleeding [see Warnings and Precautions (5.2) ] . Most common adverse reactions (≥4%) are cough, headache, throat irritation/pharyngolaryngeal pain, nausea, flushing, dyspnea, and syncope. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact United Therapeutics Corp. at 1-866-458-6479 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Pulmonary Arterial Hypertension Tyvaso DPI In a 3-week, open-label, single-sequence, safety and tolerability study (BREEZE) conducted in 51 patients on stable doses of Tyvaso Inhalation Solution who switched to a corresponding dose of Tyvaso DPI, the most commonly reported adverse events on Tyvaso DPI during the 3-week treatment phase included cough, headache, dyspnea, and nausea. Patient tolerability, as assessed by incidence of new adverse events following transition to Tyvaso DPI, was consistent with the expected known safety profile of Tyvaso Inhalation Solution. Table 1 lists the adverse events that occurred at a rate of at least 4%. Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso DPI in BREEZE (Treatment Phase) Adverse Event Tyvaso DPI (n=51) n (%) Cough 18 (35.3) Headache 8 (15.7) Dyspnea 4 (7.8) Nausea 3 (5.9) The safety of Tyvaso DPI was also studied in an extension phase of the study in which 49 patients were dosed for a duration of 43 patient-years. Fifty-nine percent (59%) of patients achieved a dose of 64 mcg, 4 times daily or higher. The adverse events during this long-term, extension phase were similar to those observed in the 3-week treatment phase. Tyvaso Inhalation Solution In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most commonly reported adverse reactions on Tyvaso Inhalation Solution included cough and throat irritation, headache, gastrointestinal effects, muscle, jaw or bone pain, dizziness, flushing, and syncope. Table 2 ...

adverse reactions table

Table 1: Adverse Events in ≥4% of PAH Patients Receiving Tyvaso DPI in BREEZE (Treatment Phase)Adverse EventTyvaso DPI (n=51) n (%)Cough18 (35.3)Headache8 (15.7)Dyspnea4 (7.8)Nausea3 (5.9)

Additional Listing Data#

Finished product: Yes
Brand name base: Tyvaso DPI
Listing expiration: 2026-12-31

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	RUM6K67ESG
Rxcui	2602751, 2602754, 2602756, 2602758, 2602760, 2602762, 2602764, 2602766, 2602767, 2602768, 2602769, 2602770, 2602771, 2602772, 2602773, 2602774, 2641906, 2641907, 2641911, 2641912

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bf	Product name	1	20260309
3a764347-294a-401b-979f-44c1c6bb101a	Product name	1	20230126
5e14eefc-ad08-9fbf-a28c-67c518b16369	Product name	5	20210727
799cd7a2-692a-4730-993b-8b702e954a56	Product name	1	20200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66302-640-03	Tyvaso DPI	1 in 1 PACKAGE	KIT	1		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66302-640-03	EA - Each	66302-640	5edeae7c-3a88-48ae-a552-725a2e3efb2e	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66302-640	TYVASO DPI (TREPROSTINIL) INHALANT TYVASO DPI (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION]	11	Current NDC, 1 package rows	20241222_ddc3d400-bcb3-4b09-aae2-0768b10a5b0f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RUM6K67ESG	TREPROSTINIL	81846-19-7	treprostinil

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2602770	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 28 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32-48 MCG Titration Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641914	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-48-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602768	{112 (treprostinil 0.016 MG Inhalation Powder [Tyvaso]) / 84 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 16-32 MCG Titration Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602774	{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641907	{112 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641912	{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-64 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727471	{112 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 48-80 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727473	{112 (treprostinil 0.064 MG Inhalation Powder [Tyvaso]) / 112 (treprostinil 0.08 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 64-80 MCG Maintenance Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602772	{16 (treprostinil 0.032 MG Inhalation Powder [Tyvaso]) / 16 (treprostinil 0.048 MG Inhalation Powder [Tyvaso]) } Pack [Tyvaso 32-48 MCG Institutional Pack]	BPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.032 MG Inhalation Powder) / 28 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	{112 (treprostinil 0.016 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	{112 (treprostinil 0.016 MG Inhalation Powder) / 84 (treprostinil 0.032 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	{112 (treprostinil 0.032 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.064 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	{112 (treprostinil 0.048 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	{112 (treprostinil 0.064 MG Inhalation Powder) / 112 (treprostinil 0.08 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	{16 (treprostinil 0.032 MG Inhalation Powder) / 16 (treprostinil 0.048 MG Inhalation Powder) } Pack	GPCK	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 16 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 32 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 48 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 64 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 80 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	TYVASO DPI 16 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602768	Tyvaso DPI 16-32 MCG Titration Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602770	Tyvaso DPI 16-32-48 MCG Titration Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641914	Tyvaso DPI 16-48-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	TYVASO DPI 32 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602772	Tyvaso DPI 32-48 MCG Institutional Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602774	Tyvaso DPI 32-48 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641907	Tyvaso DPI 32-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	TYVASO DPI 48 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641912	Tyvaso DPI 48-64 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727471	Tyvaso DPI 48-80 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	TYVASO DPI 64 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727473	Tyvaso DPI 64-80 MCG Maintenance Pack	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	TYVASO DPI 80 MCG Inhalation Powder	PSN	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	treprostinil 0.016 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	treprostinil 0.032 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	treprostinil 0.048 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	treprostinil 0.064 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	treprostinil 0.08 MG Inhalation Powder [Tyvaso]	SBD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 0.016 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 0.032 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 0.048 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 0.064 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 0.08 MG Inhalation Powder	SCD	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602751	treprostinil 16 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602767	treprostinil 16-32 MCG Titration Pack, 112 (16 MCG), 84 (32 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602769	treprostinil 16-32-48 MCG Titration Pack, 112 (16 MCG), 112 (32 MCG), 28 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641913	treprostinil 16-48-64 MCG Maintenance Pack, 112 (16 MCG), 112 (48 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602756	treprostinil 32 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602771	treprostinil 32-48 MCG Institutional Pack, 16 (32 MCG), 16 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602773	treprostinil 32-48 MCG Maintenance Pack, 112 (32 MCG), 112 (48 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641906	treprostinil 32-64 MCG Maintenance Pack, 112 (32 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602760	treprostinil 48 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2641911	treprostinil 48-64 MCG Maintenance Pack, 112 (48 MCG), 112 (64 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727470	treprostinil 48-80 MCG Titration Pack, 112 (48 MCG), 112 (80 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602764	treprostinil 64 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2727472	treprostinil 64-80 MCG Titration Pack, 112 (64 MCG), 112 (80 MCG)	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697737	treprostinil 80 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	Tyvaso 0.016 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	Tyvaso 0.032 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	Tyvaso 0.048 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	Tyvaso 0.064 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	Tyvaso 0.08 MG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602754	Tyvaso 16 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602758	Tyvaso 32 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602762	Tyvaso 48 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2602766	Tyvaso 64 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14
2697739	Tyvaso 80 MCG Inhalation Powder	SY	ddc3d400-bcb3-4b09-aae2-0768b10a5b0f	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66302-640-03	66302064003	1 KIT in 1 PACKAGE (66302-640-03) * 4 INHALANT in 1 BLISTER PACK * 4 INHALANT in 1 BLISTER PACK	1 kit	2023-06-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tyvaso DPI - United Therapeutics Corporation	United Therapeutics Corporation	2025-11-20	HUMAN PRESCRIPTION DRUG LABEL	14