Orenitram
- Product NDC
- 66302-325
- 11-digit product format
- 663020325
- Labeler code
- 66302
- Product ID
- 66302-325_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- treprostinil
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- United Therapeutics Corporation
- Application
- NDA203496
- Marketing category
- NDA
- Marketing start
- 2013-12-20
- Substance
- TREPROSTINIL
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 66302-325 | 66302-325-10 | D | Discontinued by firm | 2026-09-09 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N203496-001 | ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | |
| N203496-002 | ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | |
| N203496-003 | ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | |
| N203496-004 | ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | |
| N203496-005 | ORENITRAM | TREPROSTINIL DIOLAMINE | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N203496-001 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 |
| N203496-001 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | |
| N203496-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N203496-001 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N203496-001 | 9604901 | 2028-12-15 | Drug substance, Delist requested | 2017-03-28 | |
| N203496-001 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | |
| N203496-001 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | |
| N203496-001 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 |
| N203496-001 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 |
| N203496-002 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 |
| N203496-002 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | |
| N203496-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N203496-002 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | |
| N203496-002 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N203496-002 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | |
| N203496-002 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | |
| N203496-002 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 |
| N203496-002 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 |
| N203496-003 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 |
| N203496-003 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | |
| N203496-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N203496-003 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | |
| N203496-003 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N203496-003 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | |
| N203496-003 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | |
| N203496-003 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 |
| N203496-003 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 |
| N203496-004 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 |
| N203496-004 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | |
| N203496-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N203496-004 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | |
| N203496-004 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N203496-004 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | |
| N203496-004 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | |
| N203496-004 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 |
| N203496-004 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 |
| N203496-005 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2017-02-09 |
| N203496-005 | 7417070 | 2026-07-30 | Drug substance | 2017-02-09 | |
| N203496-005 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N203496-005 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N203496-005 | 9604901 | 2028-12-15 | Drug substance, Delist requested | 2017-03-28 | |
| N203496-005 | 8410169 | 2030-02-13 | Drug product | 2017-02-09 | |
| N203496-005 | 8349892 | 2031-01-22 | Drug product | 2017-02-09 | |
| N203496-005 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2017-02-09 |
| N203496-005 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2017-02-09 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N203496-001 | ODE-272 | 2026-10-18 |
| N203496-002 | ODE-272 | 2026-10-18 |
| N203496-003 | ODE-272 | 2026-10-18 |
| N203496-004 | ODE-272 | 2026-10-18 |
| N203496-005 | ODE-272 | 2026-10-18 |
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 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-001 | ORENITRAM | EQ 0.125MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-002 | ORENITRAM | EQ 0.25MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-003 | ORENITRAM | EQ 1MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2013-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-004 | ORENITRAM | EQ 2.5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2013-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-005 | ORENITRAM | EQ 5MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2016-10-07 | 2680178bc6a6… |
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 | N203496-001 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 9604901 | 2028-12-15 | Drug substance, Delist requested | 2017-03-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2016-07-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 7417070 | 2026-07-30 | Drug substance | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 8497393 | 2028-12-15 | Drug substance, Delist requested | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 8410169 | 2030-02-13 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 8349892 | 2031-01-22 | Drug product | 2014-01-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 8747897 | 2031-08-11 | U-2725 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | 8747897 | 2031-08-11 | U-2724 | Drug product | 2014-06-13 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | 9393203 | 2026-04-27 | U-1877 | Drug product | 2017-02-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | 7417070 | 2026-07-30 | Drug substance | 2017-02-09 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N203496-001 | ODE-272 | 2026-10-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-002 | ODE-272 | 2026-10-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-003 | ODE-272 | 2026-10-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-004 | ODE-272 | 2026-10-18 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N203496-005 | ODE-272 | 2026-10-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-001 | ODE-272 | 2026-10-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-002 | ODE-272 | 2026-10-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-003 | ODE-272 | 2026-10-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-004 | ODE-272 | 2026-10-18 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N203496-005 | ODE-272 | 2026-10-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-001 | ODE-272 | 2026-10-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-002 | ODE-272 | 2026-10-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-003 | ODE-272 | 2026-10-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-004 | ODE-272 | 2026-10-18 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N203496-005 | ODE-272 | 2026-10-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-001 | ODE-272 | 2026-10-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-002 | ODE-272 | 2026-10-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-003 | ODE-272 | 2026-10-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-004 | ODE-272 | 2026-10-18 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N203496-005 | ODE-272 | 2026-10-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-001 | ODE-272 | 2026-10-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-002 | ODE-272 | 2026-10-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-003 | ODE-272 | 2026-10-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-004 | ODE-272 | 2026-10-18 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N203496-005 | ODE-272 | 2026-10-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-001 | ODE-272 | 2026-10-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-002 | ODE-272 | 2026-10-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-003 | ODE-272 | 2026-10-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-004 | ODE-272 | 2026-10-18 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N203496-005 | ODE-272 | 2026-10-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-001 | ODE-272 | 2026-10-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-002 | ODE-272 | 2026-10-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-003 | ODE-272 | 2026-10-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-004 | ODE-272 | 2026-10-18 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N203496-005 | ODE-272 | 2026-10-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-001 | ODE-272 | 2026-10-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-002 | ODE-272 | 2026-10-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-003 | ODE-272 | 2026-10-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-004 | ODE-272 | 2026-10-18 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N203496-005 | ODE-272 | 2026-10-18 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orenitram
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TREPROSTINIL | 2.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RUM6K67ESG | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1488665 | Internal RxNorm lookup |
| 1488667 | Internal RxNorm lookup |
| 1488670 | Internal RxNorm lookup |
| 1488671 | Internal RxNorm lookup |
| 1488674 | Internal RxNorm lookup |
| 1488675 | Internal RxNorm lookup |
| 1488678 | Internal RxNorm lookup |
| 1488679 | Internal RxNorm lookup |
| 1858831 | Internal RxNorm lookup |
| 1858833 | Internal RxNorm lookup |
| 2630666 | Internal RxNorm lookup |
| 2630667 | Internal RxNorm lookup |
| 2630668 | Internal RxNorm lookup |
| 2630669 | Internal RxNorm lookup |
| 2630670 | Internal RxNorm lookup |
| 2630671 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ed2003a-c801-411e-831e-d06079bb0d7c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bf | Product name | 1 | 20260309 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66302-325-01 | Orenitram | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 24 | |
| 66302-325-02 | Orenitram | 10 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 10 | 24 | |
| 66302-325-02 | Orenitram | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | 24 | |
| 66302-325-10 | Orenitram | 10 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 10 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66302-325-01 | EA - Each | 66302-325 | 33066eee-a604-4367-9caa-8418ed5dc1eb | 1 | 2014-04-03 |
| 66302-325-02 | EA - Each | 66302-325 | f9d1bb25-9fa8-4af1-bba2-e6f25838bce0 | 1 | 2023-03-13 |
| 66302-325-10 | EA - Each | 66302-325 | 430fe523-1b64-4eba-884b-33de2a6ec445 | 1 | 2015-05-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66302-325 | ORENITRAM (TREPROSTINIL) TABLET, EXTENDED RELEASE ORENITRAM (TREPROSTINIL) KIT [UNITED THERAPEUTICS CORPORATION] | 24 | Current NDC, Legacy NDC, 4 package rows | 20241206_8ed2003a-c801-411e-831e-d06079bb0d7c.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 |
|---|---|---|---|---|---|---|
| Orenitram | TREPROSTINIL | United Therapeutics Corporation | 8ed2003a-c801-411e-831e-d06079bb0d7c | 2024-11-20 | Warnings, Adverse reactions | 203496 NDA203496 66302-325 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2630669 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 210 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 2 Titration Kit] | BPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630667 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 1 Titration Kit] | BPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630671 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram]) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram]) / 84 (12 HR treprostinil 1 MG Extended Release Oral Tablet [Orenitram]) } Pack [Orenitram Month 3 Titration Kit] | BPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630668 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 210 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) } Pack | GPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630666 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) } Pack | GPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630670 | {126 (12 HR treprostinil 0.125 MG Extended Release Oral Tablet) / 42 (12 HR treprostinil 0.25 MG Extended Release Oral Tablet) / 84 (12 HR treprostinil 1 MG Extended Release Oral Tablet) } Pack | GPCK | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488667 | Orenitram 0.125 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488671 | Orenitram 0.25 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488675 | Orenitram 1 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488679 | Orenitram 2.5 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858833 | Orenitram 5 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630667 | Orenitram Month 1 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630669 | Orenitram Month 2 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630671 | Orenitram Month 3 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488665 | treprostinil 0.125 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488670 | treprostinil 0.25 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488674 | treprostinil 1 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488678 | treprostinil 2.5 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858831 | treprostinil 5 MG 12HR Extended Release Oral Tablet | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630666 | treprostinil Oral Tablet Month 1 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630668 | treprostinil Oral Tablet Month 2 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630670 | treprostinil Oral Tablet Month 3 Titration Kit | PSN | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488667 | 12 HR treprostinil 0.125 MG Extended Release Oral Tablet [Orenitram] | SBD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488671 | 12 HR treprostinil 0.25 MG Extended Release Oral Tablet [Orenitram] | SBD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488675 | 12 HR treprostinil 1 MG Extended Release Oral Tablet [Orenitram] | SBD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488679 | 12 HR treprostinil 2.5 MG Extended Release Oral Tablet [Orenitram] | SBD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858833 | 12 HR treprostinil 5 MG Extended Release Oral Tablet [Orenitram] | SBD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488665 | 12 HR treprostinil 0.125 MG Extended Release Oral Tablet | SCD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488670 | 12 HR treprostinil 0.25 MG Extended Release Oral Tablet | SCD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488674 | 12 HR treprostinil 1 MG Extended Release Oral Tablet | SCD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488678 | 12 HR treprostinil 2.5 MG Extended Release Oral Tablet | SCD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858831 | 12 HR treprostinil 5 MG Extended Release Oral Tablet | SCD | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488667 | 12 HR Orenitram 0.125 MG Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488671 | 12 HR Orenitram 0.25 MG Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488675 | 12 HR Orenitram 1 MG Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488679 | 12 HR Orenitram 2.5 MG Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858833 | 12 HR Orenitram 5 MG Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488667 | Orenitram 0.125 MG (as treprostinil diolamine 0.159 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488671 | Orenitram 0.25 MG (as treprostinil diolamine 0.317 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488675 | Orenitram 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488679 | Orenitram 2.5 MG (as treprostinil diolamine 3.17 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858833 | Orenitram 5 MG (as treprostinil diolamine 6.35 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630667 | Orenitram Month 1 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630669 | Orenitram Month 2 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630671 | Orenitram Month 3 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488665 | treprostinil 0.125 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488665 | treprostinil 0.125 MG (as treprostinil diolamine 0.159 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488670 | treprostinil 0.25 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488670 | treprostinil 0.25 MG (as treprostinil diolamine 0.317 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488674 | treprostinil 1 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488674 | treprostinil 1 MG (as treprostinil diolamine 1.27 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488678 | treprostinil 2.5 MG (as treprostinil diethanolamine) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1488678 | treprostinil 2.5 MG (as treprostinil diolamine 3.17 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 1858831 | treprostinil 5 MG (as treprostinil diolamine 6.35 MG) 12 HR Extended Release Oral Tablet | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630666 | treprostinil Oral Tablet Month 1 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630668 | treprostinil Oral Tablet Month 2 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
| 2630670 | treprostinil Oral Tablet Month 3 Titration Kit | SY | 8ed2003a-c801-411e-831e-d06079bb0d7c | 24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 66302-325-01 | 66302032501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-325-01) | 2013-12-20 | 0000-00-00 | No | No | Current | |
| 66302-325-02 | 66302032502 | 1 BLISTER PACK in 1 CARTON (66302-325-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2021-06-30 | 0000-00-00 | No | No | Current |
| 66302-325-10 | 66302032510 | 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-325-10) | 2013-12-20 | 0000-00-00 | No | No | Current |