UPTRAVI
- Product NDC
- 66215-718
- 11-digit product format
- 662150718
- Labeler code
- 66215
- Product ID
- 66215-718_cf17e19e-ac3d-4787-88e8-f4cc7f4fcc74
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Selexipag
- Dosage form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actelion Pharmaceuticals US, Inc.
- Application
- NDA214275
- Marketing category
- NDA
- Marketing start
- 2021-07-29
- Substance
- SELEXIPAG
- Active strength
- 1800 ug/10mL
- 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 | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N214275-001 | UPTRAVI | SELEXIPAG | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 |
| N214275-001 | 7205302*PED | 2027-04-30 | Pediatric extension | ||
| N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | |
| N214275-001 | 9173881*PED | 2030-02-12 | Pediatric extension | ||
| N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | |
| N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | |
| N214275-001 | 9284280*PED | 2030-12-25 | Pediatric extension | ||
| N214275-001 | 8791122*PED | 2031-02-01 | Pediatric extension |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N214275-001 | UPTRAVI | 1.8MG/VIAL | POWDER / INTRAVENOUS | RLD, RS | 2021-07-29 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 7205302*PED | 2027-04-30 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 9173881*PED | 2030-02-12 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 9284280*PED | 2030-12-25 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N214275-001 | 8791122*PED | 2031-02-01 | Pediatric extension | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 7205302*PED | 2027-04-30 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 9173881*PED | 2030-02-12 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 9284280*PED | 2030-12-25 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N214275-001 | 8791122*PED | 2031-02-01 | Pediatric extension | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214275-001 | 7205302 | 2026-10-31 | U-1797 | Drug substance, Drug product | 2021-08-27 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214275-001 | 9173881 | 2029-08-12 | U-1798 | 2021-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214275-001 | 9284280 | 2030-06-25 | U-1831 | 2021-08-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N214275-001 | 8791122 | 2030-08-01 | Drug substance, Drug product | 2021-08-27 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- UPTRAVI
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SELEXIPAG | 1800 ug/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5EXC0E384L | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1729007 | Internal RxNorm lookup |
| 1729013 | Internal RxNorm lookup |
| 1729027 | Internal RxNorm lookup |
| 1729029 | Internal RxNorm lookup |
| 1729031 | Internal RxNorm lookup |
| 1729033 | Internal RxNorm lookup |
| 1729045 | Internal RxNorm lookup |
| 1729047 | Internal RxNorm lookup |
| 1729051 | Internal RxNorm lookup |
| 1729053 | Internal RxNorm lookup |
| 1729055 | Internal RxNorm lookup |
| 1729057 | Internal RxNorm lookup |
| 1729059 | Internal RxNorm lookup |
| 1729061 | Internal RxNorm lookup |
| 1729063 | Internal RxNorm lookup |
| 1729065 | Internal RxNorm lookup |
| 1729075 | Internal RxNorm lookup |
| 1729076 | Internal RxNorm lookup |
| 2565271 | Internal RxNorm lookup |
| 2565275 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a7a23b87-f892-4e2c-8e2e-ebf841220f90 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66215-718-01 | UPTRAVI | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, FOR SOLUTION | 10 | 25 | |
| 66215-718-01 | UPTRAVI | 1 in 1 CARTON | INJECTION, POWDER, FOR SOLUTION | 1 | 25 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66215-718-01 | EA - Each | 66215-718 | 0bfd68d0-135d-4437-a80b-19529add251b | 1 | 2021-09-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66215-718 | 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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| 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 | 214275 NDA214275 66215-718 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66215-718-01 | 66215071801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (66215-718-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2021-07-29 | 0000-00-00 | No | No | Current |