PREZCOBIX
- Product NDC
- 70518-0714
- 11-digit product format
- 705180714
- Labeler code
- 70518
- Product ID
- 70518-0714_8bc81904-01e2-a108-e053-2995a90ad60f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DARUNAVIR ETHANOLATE and COBICISTAT
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA205395
- Marketing category
- NDA
- Marketing start
- 2017-08-28
- Marketing end
- 0000-00-00
- Substance
- DARUNAVIR ETHANOLATE; COBICISTAT
- Active strength
- 800 mg/1; mg/1
- Pharmacologic classes
- HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 3A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 70518-0714 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 70518-0714 | 70518-0714-0 | D | Discontinued by firm | 2026-08-10 |
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 | 70518-0714-0 | 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 | 70518-0714-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0714-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0714-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0714-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0714-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0714-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0714-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0714-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0714-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0714-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0714-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N205395-001 | PREZCOBIX | COBICISTAT; DARUNAVIR ETHANOLATE | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | |
| N205395-002 | PREZCOBIX | COBICISTAT; DARUNAVIR ETHANOLATE | 150MG;EQ 675MG BASE | TABLET / ORAL | RLD, RS | 2025-03-21 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | |
| N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | ||
| N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 |
| N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 |
| N205395-001 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2015-02-26 |
| N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | |
| N205395-002 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2025-04-16 | |
| N205395-002 | 7700645*PED | 2027-06-26 | Pediatric extension | ||
| N205395-002 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2025-04-16 |
| N205395-002 | 10039718 | 2032-10-06 | Drug product | 2025-04-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | PREZCOBIX | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-002 | PREZCOBIX | 150MG;EQ 675MG BASE | TABLET / ORAL | RLD | 2025-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | PREZCOBIX | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-002 | PREZCOBIX | 150MG;EQ 675MG BASE | TABLET / ORAL | RLD | 2025-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | PREZCOBIX | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-002 | PREZCOBIX | 150MG;EQ 675MG BASE | TABLET / ORAL | RLD | 2025-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N205395-001 | PREZCOBIX | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N205395-001 | PREZCOBIX | 150MG;EQ 800MG BASE | TABLET / ORAL | RLD, RS | 2015-01-29 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N205395-001 | PREZCOBIX | 150MG;800MG | TABLET / ORAL | RLD, RS | 2015-01-29 | 3a93d1ddd44b… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2015-02-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-002 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2025-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-002 | 7700645*PED | 2027-06-26 | Pediatric extension | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N205395-002 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2025-04-16 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N205395-002 | 10039718 | 2032-10-06 | Drug product | 2025-04-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2015-02-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-002 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2025-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-002 | 7700645*PED | 2027-06-26 | Pediatric extension | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-002 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2025-04-16 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N205395-002 | 10039718 | 2032-10-06 | Drug product | 2025-04-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2015-02-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-002 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2025-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-002 | 7700645*PED | 2027-06-26 | Pediatric extension | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N205395-002 | 8148374 | 2029-09-03 | U-4162 | Drug substance, Drug product | 2025-04-16 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N205395-002 | 10039718 | 2032-10-06 | Drug product | 2025-04-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | 7700645 | 2026-12-26 | Drug substance, Drug product | 2015-02-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | 7700645*PED | 2027-06-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | 8148374 | 2029-09-03 | U-1279 | Drug substance, Drug product | 2015-02-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | 8148374 | 2029-09-03 | U-2939 | Drug substance, Drug product | 2015-02-26 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N205395-001 | 10039718 | 2032-10-06 | Drug product | 2018-09-05 | b8a1b40f171c… |
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 |
|---|---|---|---|---|---|---|
| PREZCOBIX | DARUNAVIR ETHANOLATE AND COBICISTAT | Janssen Products, LP | 9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f | 2026-02-01 | Warnings, Adverse reactions | 205395 NDA205395 |
| PREZCOBIX | DARUNAVIR ETHANOLATE AND COBICISTAT | A-S Medication Solutions | 16ca460a-3c89-4697-8f45-972615a2a518 | 2024-01-02 | Warnings, Adverse reactions | 205395 NDA205395 |