Treprostinil
- Product NDC
- 42023-206
- 11-digit product format
- 420230206
- Labeler code
- 42023
- Product ID
- 42023-206_1798515a-9b6d-4718-b259-8f893c14b904
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Treprostinil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA209382
- Marketing category
- ANDA
- Marketing start
- 2019-09-25
- Marketing end
- 0000-00-00
- Substance
- TREPROSTINIL
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 product | product | 42023-206 | D | Discontinued by firm | 2026-09-09 | ||
| excluded package | package | 42023-206 | 42023-206-01 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42023-206-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42023-206-01 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209382-001 | TREPROSTINIL | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | ||
| A209382-002 | TREPROSTINIL | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | ||
| A209382-003 | TREPROSTINIL | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | ||
| A209382-004 | TREPROSTINIL | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 |
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 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | 2019-09-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / IV (INFUSION), SUBCUTANEOUS | AP | 2019-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / IV (INFUSION), SUBCUTANEOUS | AP | 2019-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / IV (INFUSION), SUBCUTANEOUS | AP | 2019-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / IV (INFUSION), SUBCUTANEOUS | AP | 2019-09-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-001 | TREPROSTINIL | 1MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-002 | TREPROSTINIL | 2.5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-003 | TREPROSTINIL | 5MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-004 | TREPROSTINIL | 10MG/ML | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AP | 2019-09-24 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-08-23 18:47 UTC | 2025-08 | A209382-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209382-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209382-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209382-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209382-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209382-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209382-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209382-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209382-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209382-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209382-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209382-004 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209382-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209382-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209382-003 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209382-004 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209382-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209382-002 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209382-003 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209382-004 | AP | 1 | 301d65b070ca… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42023-206-01 | ML - Milliliter | 42023-206 | 33362dbd-5fe4-47b7-ab4c-b86db5244039 | 1 | 2019-11-12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42023-206-01 | 42023020601 | 1 VIAL in 1 CARTON (42023-206-01) > 20 mL in 1 VIAL | 1 vial | 2019-09-25 | 0000-00-00 | No | No | Current |