PIFELTRO
- Product NDC
- 50090-6237
- Requested package NDC
- 50090-6237-0
- 11-digit product format
- 500906237
- Labeler code
- 50090
- Product ID
- 50090-6237_bcf61557-ab36-4f94-b83c-9024c0cdb968
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- doravirine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA210806
- Marketing category
- NDA
- Marketing start
- 2018-07-20
- Marketing end
- 0000-00-00
- Substance
- DORAVIRINE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Non-Nucleoside Analog [EXT], Non-Nucleoside Reverse Transcriptase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50090-6237 | 50090-6237-0 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210806-001 | PIFELTRO | DORAVIRINE | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 |
| N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 |
| N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-03 20:17:24 | 2025-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | cb3db0bc1861… | |
| 2026-08-01 22:54:32 | 2026-06 | N210806-001 | PIFELTRO | 100MG | TABLET / ORAL | RLD, RS | 2018-08-30 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-03 20:17:24 | 2025-12 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | 31067a03dcf5… |
| 2026-08-03 20:17:24 | 2025-12 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | 31067a03dcf5… |
| 2026-08-03 20:17:24 | 2025-12 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210806-001 | 8486975 | 2032-08-30 | U-2630 | Drug substance, Drug product | 2018-09-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210806-001 | 8486975 | 2032-08-30 | U-2394 | Drug substance, Drug product | 2018-09-17 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210806-001 | 8486975 | 2032-08-30 | U-3308 | Drug substance, Drug product | 2018-09-17 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N210806-001 | 8486975 | 2031-10-07 | U-2394 | Drug substance, Drug product | 2018-09-17 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N210806-001 | 8486975 | 2031-10-07 | U-3308 | Drug substance, Drug product | 2018-09-17 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210806-001 | 8486975 | 2031-10-07 | U-2630 | Drug substance, Drug product | 2018-09-17 | 5c6f7cd8ea54… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-03 20:17:24 | 2025-12 | N210806-001 | NPP | 2025-01-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N210806-001 | NPP | 2025-01-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210806-001 | NPP | 2025-01-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210806-001 | NPP | 2025-01-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210806-001 | NPP | 2025-01-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210806-001 | NPP | 2025-01-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210806-001 | NPP | 2025-01-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210806-001 | NPP | 2025-01-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N210806-001 | NPP | 2025-01-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210806-001 | NPP | 2025-01-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210806-001 | NPP | 2025-01-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210806-001 | NPP | 2025-01-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N210806-001 | NPP | 2025-01-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210806-001 | I-827 | 2022-09-19 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210806-001 | NCE | 2023-08-30 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N210806-001 | NPP | 2025-01-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N210806-001 | I-827 | 2022-09-19 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N210806-001 | NCE | 2023-08-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N210806-001 | I-827 | 2022-09-19 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | N210806-001 | NCE | 2023-08-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N210806-001 | NCE | 2023-08-30 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N210806-001 | I-827 | 2022-09-19 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | N210806-001 | NCE | 2023-08-30 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N210806-001 | I-827 | 2022-09-19 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | N210806-001 | NCE | 2023-08-30 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N210806-001 | I-827 | 2022-09-19 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N210806-001 | NCE | 2023-08-30 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N210806-001 | I-827 | 2022-09-19 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N210806-001 | NCE | 2023-08-30 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N210806-001 | I-827 | 2022-09-19 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N210806-001 | NCE | 2023-08-30 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N210806-001 | I-827 | 2022-09-19 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N210806-001 | NCE | 2023-08-30 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N210806-001 | NCE | 2023-08-30 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N210806-001 | NCE | 2023-08-30 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N210806-001 | NCE | 2023-08-30 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N210806-001 | NPP | 2025-01-27 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N210806-001 | NPP | 2025-01-27 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N210806-001 | NCE | 2023-08-30 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N210806-001 | NPP | 2025-01-27 | ea1830bbd6c7… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PIFELTRO | DORAVIRINE | A-S Medication Solutions | ff06e5cc-f47a-4779-816b-0e5b13e88a25 | 2026-07-09 | Warnings, Adverse reactions | 210806 NDA210806 |
| PIFELTRO | DORAVIRINE | Merck Sharp & Dohme LLC | 76ce1f00-28c0-4314-bd2c-d473fe3d0970 | 2026-07-08 | Warnings, Adverse reactions | 210806 NDA210806 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6237-0 | EA - Each | 50090-6237 | 17803e4f-964b-4b6f-86a9-11e21b75db6c | 1 | 2023-01-09 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-6237-0 | 50090623700 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6237-0) | 2022-11-21 | 0000-00-00 | No | No | Current |