UPTRAVI

Product NDC: 66215-614
11-digit product format: 662150614
Labeler code: 66215
Product ID: 66215-614_cf17e19e-ac3d-4787-88e8-f4cc7f4fcc74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Selexipag
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Actelion Pharmaceuticals US, Inc.
Application: NDA207947
Marketing category: NDA
Marketing start: 2015-12-21
Substance: SELEXIPAG
Active strength: 1400 ug/1
Pharmacologic classes: Prostacyclin Receptor Agonist [EPC], Prostacyclin Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N207947-001	UPTRAVI	SELEXIPAG	0.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-002	UPTRAVI	SELEXIPAG	0.4MG	TABLET / ORAL	AB	RLD, RS	2015-12-21
N207947-003	UPTRAVI	SELEXIPAG	0.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-004	UPTRAVI	SELEXIPAG	0.8MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-005	UPTRAVI	SELEXIPAG	1MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-006	UPTRAVI	SELEXIPAG	1.2MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-007	UPTRAVI	SELEXIPAG	1.4MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-008	UPTRAVI	SELEXIPAG	1.6MG	TABLET / ORAL	AB	RLD	2015-12-21
N207947-010	UPTRAVI	SELEXIPAG	0.1MG	TABLET / ORAL		RLD	2026-05-23
N207947-011	UPTRAVI	SELEXIPAG	0.15MG	TABLET / ORAL		RLD	2026-05-23

Therapeutic equivalence codes#

Application-product, TE code table
Application-product	TE code
N207947-001	AB
N207947-002	AB
N207947-003	AB
N207947-004	AB
N207947-005	AB
N207947-006	AB
N207947-007	AB
N207947-008	AB

Orange Book patents#

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207947-001	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-001	7205302*PED	2027-04-30		Pediatric extension
N207947-001	9173881	2029-08-12	U-1798		2016-01-19
N207947-001	9173881*PED	2030-02-12		Pediatric extension
N207947-001	9284280	2030-06-25	U-1831		2016-04-12
N207947-001	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-001	9284280*PED	2030-12-25		Pediatric extension
N207947-001	8791122*PED	2031-02-01		Pediatric extension
N207947-001	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-001	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-001	10821108*PED	2037-06-01		Pediatric extension
N207947-001	10828298*PED	2037-06-01		Pediatric extension
N207947-002	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-002	7205302*PED	2027-04-30		Pediatric extension
N207947-002	9173881	2029-08-12	U-1798		2016-01-19
N207947-002	9173881*PED	2030-02-12		Pediatric extension
N207947-002	9284280	2030-06-25	U-1831		2016-04-12
N207947-002	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-002	9284280*PED	2030-12-25		Pediatric extension
N207947-002	8791122*PED	2031-02-01		Pediatric extension
N207947-002	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-002	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-002	10821108*PED	2037-06-01		Pediatric extension
N207947-002	10828298*PED	2037-06-01		Pediatric extension
N207947-003	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-003	7205302*PED	2027-04-30		Pediatric extension
N207947-003	9173881	2029-08-12	U-1798		2016-01-19
N207947-003	9173881*PED	2030-02-12		Pediatric extension
N207947-003	9284280	2030-06-25	U-1831		2016-04-12
N207947-003	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-003	9284280*PED	2030-12-25		Pediatric extension
N207947-003	8791122*PED	2031-02-01		Pediatric extension
N207947-003	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-003	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-003	10821108*PED	2037-06-01		Pediatric extension
N207947-003	10828298*PED	2037-06-01		Pediatric extension
N207947-004	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-004	7205302*PED	2027-04-30		Pediatric extension
N207947-004	9173881	2029-08-12	U-1798		2016-01-19
N207947-004	9173881*PED	2030-02-12		Pediatric extension
N207947-004	9284280	2030-06-25	U-1831		2016-04-12
N207947-004	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-004	9284280*PED	2030-12-25		Pediatric extension
N207947-004	8791122*PED	2031-02-01		Pediatric extension
N207947-004	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-004	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-004	10821108*PED	2037-06-01		Pediatric extension
N207947-004	10828298*PED	2037-06-01		Pediatric extension
N207947-005	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-005	7205302*PED	2027-04-30		Pediatric extension
N207947-005	9173881	2029-08-12	U-1798		2016-01-19
N207947-005	9173881*PED	2030-02-12		Pediatric extension
N207947-005	9284280	2030-06-25	U-1831		2016-04-12
N207947-005	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-005	9284280*PED	2030-12-25		Pediatric extension
N207947-005	8791122*PED	2031-02-01		Pediatric extension
N207947-005	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-005	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-005	10821108*PED	2037-06-01		Pediatric extension
N207947-005	10828298*PED	2037-06-01		Pediatric extension
N207947-006	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-006	7205302*PED	2027-04-30		Pediatric extension
N207947-006	9173881	2029-08-12	U-1798		2016-01-19
N207947-006	9173881*PED	2030-02-12		Pediatric extension
N207947-006	9284280	2030-06-25	U-1831		2016-04-12
N207947-006	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-006	9284280*PED	2030-12-25		Pediatric extension
N207947-006	8791122*PED	2031-02-01		Pediatric extension
N207947-006	10821108	2036-12-01	U-2992	Drug product	2020-12-02
N207947-006	10828298	2036-12-01	U-2991	Drug product	2020-12-02
N207947-006	10821108*PED	2037-06-01		Pediatric extension
N207947-006	10828298*PED	2037-06-01		Pediatric extension
N207947-007	7205302	2026-10-31	U-1797	Drug substance, Drug product	2016-01-19
N207947-007	7205302*PED	2027-04-30		Pediatric extension
N207947-007	9173881	2029-08-12	U-1798		2016-01-19
N207947-007	9173881*PED	2030-02-12		Pediatric extension
N207947-007	9284280	2030-06-25	U-1831		2016-04-12
N207947-007	8791122	2030-08-01		Drug substance, Drug product	2016-01-19
N207947-007	9284280*PED	2030-12-25		Pediatric extension
N207947-007	8791122*PED	2031-02-01		Pediatric extension

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N207947-001	NPP	2029-05-23
N207947-001	PED	2029-11-23
N207947-002	NPP	2029-05-23
N207947-002	PED	2029-11-23
N207947-003	NPP	2029-05-23
N207947-003	PED	2029-11-23
N207947-004	NPP	2029-05-23
N207947-004	PED	2029-11-23
N207947-005	NPP	2029-05-23
N207947-005	PED	2029-11-23
N207947-006	NPP	2029-05-23
N207947-006	PED	2029-11-23
N207947-007	NPP	2029-05-23
N207947-007	PED	2029-11-23
N207947-008	NPP	2029-05-23
N207947-008	PED	2029-11-23
N207947-010	NS	2029-05-23
N207947-010	PED	2029-11-23
N207947-011	NS	2029-05-23
N207947-011	PED	2029-11-23

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
UPTRAVI	SELEXIPAG	Actelion Pharmaceuticals US, Inc.	a7a23b87-f892-4e2c-8e2e-ebf841220f90	2026-05-28	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 Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment. ( 5.1 ) 5.1 Pulmonary Edema with Pulmonary Veno-Occlusive Disease Should signs of pulmonary edema occur, consider the possibility of associated pulmonary veno-occlusive disease. If confirmed, discontinue UPTRAVI.

Adverse reactions cross-check#

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

adverse reactions

6 ADVERSE REACTIONS Adverse reactions in adult and pediatric patients occurring more frequently (≥5%) on UPTRAVI compared to placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing. Additional adverse reaction occurring in pediatric patients more frequently (≥5%) on UPTRAVI compared to placebo is abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actelion at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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. UPTRAVI Tablets Adult Patients The safety of UPTRAVI tablets has been evaluated in a long-term, placebo-controlled study enrolling 1,156 adult patients with symptomatic PAH (GRIPHON study) [see Clinical Studies (14.1) ] . The exposure to UPTRAVI in this trial was up to 4.2 years with median duration of exposure of 1.4 years. Table 3 presents adverse reactions more frequent on UPTRAVI tablets than on placebo by ≥3%. Table 3: Adverse Reactions UPTRAVI Placebo Adverse Reaction N=575 N=577 Headache 65% 32% Diarrhea 42% 18% Jaw pain 26% 6% Nausea 33% 18% Myalgia 16% 6% Vomiting 18% 9% Pain in extremity 17% 8% Flushing 12% 5% Arthralgia 11% 8% Anemia 8% 5% Decreased appetite 6% 3% Rash 11% 8% These adverse reactions are more frequent during the dose titration phase. Hyperthyroidism was observed in 1% (n=8) of patients on UPTRAVI tablets and in none of the patients on placebo. Pediatric Patients Two Years and Older The safety of UPTRAVI tablets has been evaluated in a long-term, Phase 3, double-blind, placebo-controlled study (SALTO), where a total of 138 pediatric patients with symptomatic PAH ≥2 to

adverse reactions table

Table 3: Adverse ReactionsUPTRAVIPlaceboAdverse ReactionN=575N=577Headache65%32%Diarrhea42%18%Jaw pain26%6%Nausea33%18%Myalgia16%6%Vomiting18%9%Pain in extremity17%8%Flushing12%5%Arthralgia11%8%Anemia8%5%Decreased appetite6%3%Rash11%8%

Additional Listing Data#

Finished product: Yes
Brand name base: UPTRAVI
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SELEXIPAG	1400 ug/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	5EXC0E384L
Rxcui	1729007, 1729013, 1729027, 1729029, 1729031, 1729033, 1729045, 1729047, 1729051, 1729053, 1729055, 1729057, 1729059, 1729061, 1729063, 1729065, 1729075, 1729076, 2565271, 2565275

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3940235d-2369-40fe-94e3-68f58494a1a8	Product name	3	20250627
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66215-614-06	UPTRAVI	1 in 1 CARTON	TABLET, COATED	1		25
66215-614-06	UPTRAVI	60 in 1 BOTTLE	TABLET, COATED	60		25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66215-614-06	EA - Each	66215-614	4d628f03-a37e-4aaa-9188-ad0559b32d73	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66215-614	UPTRAVI (SELEXIPAG) TABLET, COATED UPTRAVI TITRATION PACK (SELEXIPAG) KIT UPTRAVI (SELEXIPAG) INJECTION, POWDER, FOR SOLUTION [ACTELION PHARMACEUTICALS US, INC.]	24	Current NDC, Legacy NDC, 2 package rows	20240709_a7a23b87-f892-4e2c-8e2e-ebf841220f90.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5EXC0E384L	SELEXIPAG	475086-01-2	SELEXIPAG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1729076	{140 (selexipag 0.2 MG Oral Tablet [Uptravi]) / 60 (selexipag 0.8 MG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]	BPCK	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	{140 (selexipag 0.2 MG Oral Tablet) / 60 (selexipag 0.8 MG Oral Tablet) } Pack	GPCK	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1000 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565271	selexipag 1800 MCG Injection	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	selexipag 200 MCG (140), selexipag 800 MCG (60) Oral Tablet Titration Pack	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 800 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1000 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	Uptravi 1400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	Uptravi 1600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1800 MCG Injection	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 200 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 400 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 600 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 800 MCG Oral Tablet	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	Uptravi Titration Pack	PSN	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	selexipag 0.2 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	selexipag 0.4 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	selexipag 0.6 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	selexipag 0.8 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	selexipag 1 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	selexipag 1.2 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	selexipag 1.4 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	selexipag 1.6 MG Oral Tablet [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	selexipag 1.8 MG Injection [Uptravi]	SBD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 0.2 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 0.4 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 0.6 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 0.8 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1.2 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1.4 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1.6 MG Oral Tablet	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565271	selexipag 1.8 MG Injection	SCD	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	{140 (selexipag 200 MCG Oral Tablet [Uptravi]) / 60 (selexipag 800 MCG Oral Tablet [Uptravi]) } Pack [Uptravi Titration Pack]	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729075	{140 (selexipag 200 MCG Oral Tablet) / 60 (selexipag 800 MCG Oral Tablet) } Pack	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729007	selexipag 1000 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729027	selexipag 1200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729031	selexipag 1400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729045	selexipag 1600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729051	selexipag 200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729055	selexipag 400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729059	selexipag 600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729063	selexipag 800 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 0.2 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 0.4 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 0.6 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 0.8 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1.2 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729033	Uptravi 1.4 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729047	Uptravi 1.6 MG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1.8 MG Injection	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729013	Uptravi 1000 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729029	Uptravi 1200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
2565275	Uptravi 1800 MCG Injection	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729053	Uptravi 200 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729057	Uptravi 400 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729061	Uptravi 600 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729065	Uptravi 800 MCG Oral Tablet	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26
1729076	Uptravi Titration Pack	SY	a7a23b87-f892-4e2c-8e2e-ebf841220f90	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66215-614-06	66215061406	1 BOTTLE in 1 CARTON (66215-614-06) / 60 TABLET, COATED in 1 BOTTLE	1 bottle	2015-12-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
UPTRAVI	Actelion Pharmaceuticals US, Inc. \| Butterworth Laboratories Ltd \| Wickham Micro Limited \| Almac Sciences Limited \| Almac Pharma Services Limited \| EUROFINS AMATSIGROUP SAS \| Eurofins Amatsi Analytics \| SGS Institut Fresenius GmbH \| Excella GmbH & Co. KG \| Konapharma AG \| Confarma France	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	26