VOQUEZNA TRIPLE PAK
- Product NDC
- 81520-255
- 11-digit product format
- 815200255
- Labeler code
- 81520
- Product ID
- 81520-255_5acd62cf-6c95-479f-9cab-22febc716a4f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vonoprazan fumarate, amoxicillin and clarithromycin
- Dosage form
- KIT
- Labeler
- Phathom Pharmaceuticals Inc.
- Application
- NDA215152
- Marketing category
- NDA
- Marketing start
- 2023-11-08
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N215152-001 | VOQUEZNA TRIPLE PAK | AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N215152-001 | 7977488 | 2030-04-10 | Drug substance | 2022-07-27 | |
| N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N215152-001 | NCE | 2027-05-03 |
| N215152-001 | GAIN | 2032-05-03 |
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 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 5c6f7cd8ea54… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD | 2022-05-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N215152-001 | VOQUEZNA TRIPLE PAK | 500MG;500MG;EQ 20MG BASE | CAPSULE, TABLET, TABLET / ORAL | RLD, RS | 2022-05-03 | a50c72e98297… |
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 | N215152-001 | 7977488 | 2030-04-10 | Drug substance | 2022-07-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | 7977488 | 2028-08-11 | Drug substance | 2022-07-27 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N215152-001 | 9186411 | 2030-08-11 | Drug product | 2022-07-27 | a67488948f0b… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | NCE | 2027-05-03 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N215152-001 | GAIN | 2032-05-03 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | NCE | 2027-05-03 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N215152-001 | GAIN | 2032-05-03 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | NCE | 2027-05-03 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N215152-001 | GAIN | 2032-05-03 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | NCE | 2027-05-03 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N215152-001 | GAIN | 2032-05-03 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | NCE | 2027-05-03 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N215152-001 | GAIN | 2032-05-03 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | NCE | 2027-05-03 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N215152-001 | GAIN | 2032-05-03 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | NCE | 2027-05-03 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N215152-001 | GAIN | 2032-05-03 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | NCE | 2027-05-03 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N215152-001 | GAIN | 2032-05-03 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | NCE | 2027-05-03 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N215152-001 | GAIN | 2032-05-03 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | NCE | 2027-05-03 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N215152-001 | GAIN | 2032-05-03 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | NCE | 2027-05-03 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N215152-001 | GAIN | 2032-05-03 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | NCE | 2027-05-03 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N215152-001 | GAIN | 2032-05-03 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | NCE | 2027-05-03 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N215152-001 | GAIN | 2032-05-03 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | NCE | 2027-05-03 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N215152-001 | GAIN | 2032-05-03 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | NCE | 2027-05-03 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N215152-001 | GAIN | 2032-05-03 | 5c6f7cd8ea54… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | NCE | 2027-05-03 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N215152-001 | GAIN | 2032-05-03 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | NCE | 2027-05-03 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N215152-001 | GAIN | 2032-05-03 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | NCE | 2027-05-03 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N215152-001 | GAIN | 2032-05-03 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | NCE | 2027-05-03 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N215152-001 | GAIN | 2032-05-03 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | NCE | 2027-05-03 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N215152-001 | GAIN | 2032-05-03 | 9b2671bbb829… |
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 |
|---|---|---|---|---|---|---|
| VOQUEZNA DUAL PAK | VONOPRAZAN FUMARATE AND AMOXICILLIN | Phathom Pharmaceuticals Inc. | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 2026-07-16 | Warnings, Adverse reactions | 215152 NDA215152 81520-255 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VOQUEZNA TRIPLE PAK
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0cb2ee04-8581-46c8-a781-7be170ab5c86 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 502415e5-4ac7-4266-a01a-ef44aa3c028d | Product name | 7 | 20250623 |
| d0f377c9-74d8-e2e3-e06e-4d37534f5c0f | Product name | 3 | 20250620 |
| ec567ae0-eedb-46c6-8d48-5818685294f7 | Product name | 1 | 20250307 |
| 594e2c86-3079-4e6e-96c9-48f7a8afc78d | Product name | 1 | 20230718 |
| 2ebbc361-d28f-48a9-a286-c1ae09cdaf5c | Product name | 3 | 20230314 |
| 2bb254ff-3d7f-4bdb-abf9-476506008c55 | Product name | 1 | 20230117 |
| e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2 | Product name | 7 | 20221114 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| f33561b9-47cb-411c-a228-16c62e346cd4 | Product name | 1 | 20200415 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 8690a824-4bf8-4d1e-b118-2d6dda86bc04 | Product name | 2 | 20161206 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| cf3f1c02-1f32-2322-3314-b70ebbf5610e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 81520-255-01 | VOQUEZNA TRIPLE PAK | 1 in 1 BLISTER PACK | KIT | 1 | 16 | |
| 81520-255-14 | VOQUEZNA TRIPLE PAK | 14 in 1 CARTON | KIT | 14 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 81520-255-01 | EA - Each | 81520-255 | 5f63c9cc-8e6c-48c3-a798-f4b4b276ecba | 1 | 2022-06-06 |
| 81520-255-14 | EA - Each | 81520-255 | dca9de80-585e-4109-a80a-5cc0ff556456 | 1 | 2022-06-06 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 81520-255 | VOQUEZNA DUAL PAK (VONOPRAZAN FUMARATE AND AMOXICILLIN) KIT VOQUEZNA TRIPLE PAK (VONOPRAZAN FUMARATE, AMOXICILLIN AND CLARITHROMYCIN) KIT [PHATHOM PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250524_0cb2ee04-8581-46c8-a781-7be170ab5c86.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604804 | {56 (amoxicillin 500 MG Oral Capsule) / 28 (clarithromycin 500 MG Oral Tablet) / 28 (vonoprazan 20 MG Oral Tablet) } Pack [Voquezna 14 Day TriplePak 20;500;500] | BPCK | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604802 | {84 (amoxicillin 500 MG Oral Capsule) / 28 (vonoprazan 20 MG Oral Tablet) } Pack [Voquezna 14 Day DualPak 20;500] | BPCK | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604803 | {56 (amoxicillin 500 MG Oral Capsule) / 28 (clarithromycin 500 MG Oral Tablet) / 28 (vonoprazan 20 MG Oral Tablet) } Pack | GPCK | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604801 | {84 (amoxicillin 500 MG Oral Capsule) / 28 (vonoprazan 20 MG Oral Tablet) } Pack | GPCK | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604803 | amoxicillin 500 MG (56) / clarithromycin 500 MG (28) / vonoprazan 20 MG (28) 14 Day TriplePak Oral Pack | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604801 | amoxicillin 500 MG (84) / vonoprazan 20 MG (28) 14 Day DualPak Oral Pack | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 308191 | amoxicillin 500 MG Oral Capsule | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 197517 | clarithromycin 500 MG Oral Tablet | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604800 | vonoprazan 20 MG Oral Tablet | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604802 | Voquezna 14 Day DualPak 20 MG; 500 MG | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604804 | Voquezna 14 Day TriplePak 20 MG; 500 MG; 500 MG | PSN | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 308191 | amoxicillin 500 MG Oral Capsule | SCD | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 197517 | clarithromycin 500 MG Oral Tablet | SCD | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604800 | vonoprazan 20 MG Oral Tablet | SCD | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 308191 | amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604803 | amoxicillin 500 MG (56) / clarithromycin 500 MG (28) / vonoprazan 20 MG (28) 14 Day TriplePak Oral Pack | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604801 | amoxicillin 500 MG (84) / vonoprazan 20 MG (28) 14 Day DualPak Oral Pack | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604800 | vonoprazan 20 MG (as vonoprazan fumarate 26.72 mg) Oral Tablet | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604802 | Voquezna 14 Day DualPak 20 MG; 500 MG Pack | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
| 2604804 | Voquezna 14 Day TriplePak 20 MG; 500 MG; 500 MG Pack | SY | 0cb2ee04-8581-46c8-a781-7be170ab5c86 | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 81520-255-01 | 81520025501 | 1 in 1 BLISTER PACK | Historical | |||||
| 81520-255-14 | 81520025514 | 14 BLISTER PACK in 1 CARTON (81520-255-14) / 1 KIT in 1 BLISTER PACK (81520-255-01) | 14 blister pack | 2023-11-08 | 0000-00-00 | No | No | Current |