Dexlansoprazole
- Product NDC
- 50090-5956
- 11-digit product format
- 500905956
- Labeler code
- 50090
- Product ID
- 50090-5956_dc2581d1-3173-4915-b53c-e89dd6e1c1a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexlansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- NDA022287
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-01-01
- Marketing end
- 0000-00-00
- Substance
- DEXLANSOPRAZOLE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- 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 | 50090-5956 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 50090-5956 | 50090-5956-0 | D | Discontinued by firm | 2026-09-14 |
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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 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 | 50090-5956-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022287-001 | DEXILANT | DEXLANSOPRAZOLE | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 |
| N022287-002 | DEXILANT | DEXLANSOPRAZOLE | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N022287-001 | AB |
| N022287-002 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N022287-001 | 8461187 | 2026-01-17 | Drug product | ||
| N022287-001 | 9238029 | 2026-01-17 | Drug product | 2016-02-11 | |
| N022287-001 | 9011926 | 2026-02-24 | Drug product | 2015-05-01 | |
| N022287-001 | 8461187*PED | 2026-07-17 | Pediatric extension | ||
| N022287-001 | 7790755 | 2026-08-02 | Drug product | 2010-09-29 | |
| N022287-001 | 8105626 | 2026-09-27 | Drug product | 2012-02-28 | |
| N022287-001 | 7790755*PED | 2027-02-02 | Pediatric extension | ||
| N022287-001 | 8105626*PED | 2027-03-27 | Pediatric extension | ||
| N022287-001 | 8871273 | 2028-01-11 | Drug product | 2014-12-01 | |
| N022287-001 | 8173158 | 2030-03-17 | U-949 | 2012-06-01 | |
| N022287-001 | 8173158 | 2030-03-17 | U-950 | 2012-06-01 | |
| N022287-001 | 8173158 | 2030-03-17 | U-951 | 2012-06-01 | |
| N022287-001 | 8173158*PED | 2030-09-17 | Pediatric extension | ||
| N022287-001 | 9233103 | 2032-03-05 | U-1805 | 2016-02-11 | |
| N022287-002 | 8461187 | 2026-01-17 | Drug product | ||
| N022287-002 | 9238029 | 2026-01-17 | Drug product | 2016-02-11 | |
| N022287-002 | 9011926 | 2026-02-24 | Drug product | 2015-05-01 | |
| N022287-002 | 8461187*PED | 2026-07-17 | Pediatric extension | ||
| N022287-002 | 7790755 | 2026-08-02 | Drug product | ||
| N022287-002 | 8105626 | 2026-09-27 | Drug product | ||
| N022287-002 | 7790755*PED | 2027-02-02 | Pediatric extension | ||
| N022287-002 | 8105626*PED | 2027-03-27 | Pediatric extension | ||
| N022287-002 | 8871273 | 2028-01-11 | Drug product | 2014-12-01 | |
| N022287-002 | 8173158 | 2030-03-17 | U-949 | ||
| N022287-002 | 8173158 | 2030-03-17 | U-950 | ||
| N022287-002 | 8173158 | 2030-03-17 | U-951 | ||
| N022287-002 | 8173158*PED | 2030-09-17 | Pediatric extension | ||
| N022287-002 | 9233103 | 2032-03-05 | U-1805 | 2016-02-11 |
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 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD | 2009-01-30 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2009-01-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2009-01-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2009-01-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-001 | DEXILANT | 30MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2009-01-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-002 | DEXILANT | 60MG | CAPSULE, DELAYED RELEASE / ORAL | AB | RLD, RS | 2009-01-30 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N022287-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N022287-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N022287-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022287-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022287-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N022287-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N022287-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022287-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022287-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022287-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022287-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022287-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022287-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022287-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022287-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022287-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022287-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022287-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022287-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N022287-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N022287-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022287-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022287-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022287-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022287-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022287-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N022287-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N022287-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N022287-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022287-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N022287-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N022287-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N022287-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N022287-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022287-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N022287-002 | AB | 1 | 5aa47cf7b7d7… |
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 | N022287-001 | 8461187 | 2026-01-17 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 9238029 | 2026-01-17 | Drug product | 2016-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 9011926 | 2026-02-24 | Drug product | 2015-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8461187*PED | 2026-07-17 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 7790755 | 2026-08-02 | Drug product | 2010-09-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8105626 | 2026-09-27 | Drug product | 2012-02-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 7790755*PED | 2027-02-02 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8105626*PED | 2027-03-27 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8871273 | 2028-01-11 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8173158 | 2030-03-17 | U-951 | 2012-06-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8173158 | 2030-03-17 | U-949 | 2012-06-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8173158 | 2030-03-17 | U-950 | 2012-06-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 8173158*PED | 2030-09-17 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-001 | 9233103 | 2032-03-05 | U-1805 | 2016-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8461187 | 2026-01-17 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 9238029 | 2026-01-17 | Drug product | 2016-02-11 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 9011926 | 2026-02-24 | Drug product | 2015-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8461187*PED | 2026-07-17 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 7790755 | 2026-08-02 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8105626 | 2026-09-27 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 7790755*PED | 2027-02-02 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8105626*PED | 2027-03-27 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8871273 | 2028-01-11 | Drug product | 2014-12-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8173158 | 2030-03-17 | U-951 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8173158 | 2030-03-17 | U-950 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8173158 | 2030-03-17 | U-949 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 8173158*PED | 2030-09-17 | Pediatric extension | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N022287-002 | 9233103 | 2032-03-05 | U-1805 | 2016-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8461187 | 2026-01-17 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 9238029 | 2026-01-17 | Drug product | 2016-02-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 9011926 | 2026-02-24 | Drug product | 2015-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8461187*PED | 2026-07-17 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 7790755 | 2026-08-02 | Drug product | 2010-09-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8105626 | 2026-09-27 | Drug product | 2012-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 7790755*PED | 2027-02-02 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8105626*PED | 2027-03-27 | Pediatric extension | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8871273 | 2028-01-11 | Drug product | 2014-12-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8173158 | 2030-03-17 | U-951 | 2012-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8173158 | 2030-03-17 | U-949 | 2012-06-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022287-001 | 8173158 | 2030-03-17 | U-950 | 2012-06-01 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-001 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N022287-002 | NPP | 2019-07-08 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-001 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-001 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-001 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-002 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-002 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N022287-002 | NPP | 2019-07-08 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-001 | NPP | 2019-07-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-001 | NPP | 2019-07-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-001 | NPP | 2019-07-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-002 | NPP | 2019-07-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-002 | NPP | 2019-07-08 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N022287-002 | NPP | 2019-07-08 | ea99ee380514… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-5956-0 | EA - Each | 50090-5956 | 569d7752-7649-4842-a835-5b4ba30cce4b | 1 | 2022-07-06 |
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 |
|---|---|---|---|---|---|---|
| Dexilant | DEXLANSOPRAZOLE | Takeda Pharmaceuticals America, Inc. | 9819f033-3bbe-442e-8e92-45fec77b237d | 2025-02-17 | Warnings, Adverse reactions | 022287 NDA022287 |
| Dexlansoprazole delayed release | DEXLANSOPRAZOLE | A-S Medication Solutions | 7c7698da-3cda-4301-ae93-02fb64b9c90d | 2023-11-22 | Warnings, Adverse reactions | 022287 NDA022287 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50090-5956-0 | 50090595600 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5956-0) | 2022-04-06 | 0000-00-00 | No | No | Current |