National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:53:43
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66302-105-01 | ML - Milliliter | 66302-105 | dca1f024-fd77-4fc3-b53c-e5e9b6f13715 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66302-105 | 66302-105-01 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021272-001 | REMODULIN | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 |
| N021272-002 | REMODULIN | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 |
| N021272-003 | REMODULIN | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 |
| N021272-004 | REMODULIN | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 |
| N021272-005 | REMODULIN | TREPROSTINIL | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | |
| N021272-006 | REMODULIN | TREPROSTINIL | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | |
| N021272-007 | REMODULIN | TREPROSTINIL | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | |
| N021272-008 | REMODULIN | TREPROSTINIL | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021272-001 | AP |
| N021272-002 | AP |
| N021272-003 | AP |
| N021272-004 | AP |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N021272-001 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | |
| N021272-001 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | |
| N021272-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N021272-001 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N021272-001 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2011-08-23 |
| N021272-002 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | |
| N021272-002 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | |
| N021272-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N021272-002 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N021272-002 | 7999007 | 2029-03-29 | U-1437 | Drug product | |
| N021272-003 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | |
| N021272-003 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | |
| N021272-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N021272-003 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N021272-003 | 7999007 | 2029-03-29 | U-1437 | Drug product | |
| N021272-004 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | |
| N021272-004 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | |
| N021272-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N021272-004 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | |
| N021272-004 | 7999007 | 2029-03-29 | U-1437 | Drug product | |
| N021272-005 | 8653137 | 2028-09-05 | U-1437 | 2021-08-24 | |
| N021272-005 | 8658694 | 2028-09-05 | U-1437 | 2021-08-24 | |
| N021272-005 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | |
| N021272-005 | 9593066 | 2028-12-15 | Drug substance | 2021-08-24 | |
| N021272-005 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2021-08-24 |
| N021272-006 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-006 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-006 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-006 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-006 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 |
| N021272-007 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-007 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-007 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-007 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-007 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 |
| N021272-008 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-008 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | |
| N021272-008 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-008 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | |
| N021272-008 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | REMODULIN | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | REMODULIN | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | REMODULIN | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | REMODULIN | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | REMODULIN | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | REMODULIN | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | REMODULIN | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | REMODULIN | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021272-001 | REMODULIN | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-002 | REMODULIN | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-003 | REMODULIN | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-004 | REMODULIN | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-005 | REMODULIN | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021272-006 | REMODULIN | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021272-007 | REMODULIN | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021272-008 | REMODULIN | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-001 | REMODULIN | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-002 | REMODULIN | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-003 | REMODULIN | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-004 | REMODULIN | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-005 | REMODULIN | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-006 | REMODULIN | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-007 | REMODULIN | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-008 | REMODULIN | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-001 | REMODULIN | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-002 | REMODULIN | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-003 | REMODULIN | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-004 | REMODULIN | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-005 | REMODULIN | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-006 | REMODULIN | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-007 | REMODULIN | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-008 | REMODULIN | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-001 | REMODULIN | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-002 | REMODULIN | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-003 | REMODULIN | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-004 | REMODULIN | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2002-05-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-005 | REMODULIN | 20MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2021-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-006 | REMODULIN | 0.1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-007 | REMODULIN | 0.2MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD | 2023-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-008 | REMODULIN | 0.4MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | RLD, RS | 2023-09-28 | 6a471c1ec25d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021272-004 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021272-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021272-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021272-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021272-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021272-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021272-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021272-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021272-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021272-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021272-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021272-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021272-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021272-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021272-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021272-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021272-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021272-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021272-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021272-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021272-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021272-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021272-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021272-004 | AP | 1 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-001 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2011-08-23 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-002 | 7999007 | 2029-03-29 | U-1437 | Drug product | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-003 | 7999007 | 2029-03-29 | U-1437 | Drug product | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | 8653137 | 2028-09-05 | U-1437 | 2014-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | 8658694 | 2028-09-05 | U-1437 | 2014-02-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | 9593066 | 2028-12-15 | Drug substance | 2017-03-14 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-004 | 7999007 | 2029-03-29 | U-1437 | Drug product | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | 8653137 | 2028-09-05 | U-1437 | 2021-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | 8658694 | 2028-09-05 | U-1437 | 2021-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | 11723887 | 2028-12-15 | Drug substance | 2023-08-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | 9593066 | 2028-12-15 | Drug substance | 2021-08-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-005 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2021-08-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-006 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-007 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | 8653137 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | 8658694 | 2028-09-05 | U-1437 | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | 11723887 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | 9593066 | 2028-12-15 | Drug substance | 2023-10-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021272-008 | 7999007 | 2029-03-29 | U-1437 | Drug product | 2023-10-20 | 84e616aacf4f… |
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 |
|---|---|---|---|---|---|---|
| Remodulin | TREPROSTINIL | United Therapeutics Corporation | 6c80bb38-e8db-4138-9f0d-dbbf9c673185 | 2026-07-02 | Warnings, Adverse reactions | 66302-105-01 66302010501 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.