ADHANSIA XR
- Product NDC
- 72912-535
- Requested package NDC
- 72912-535-30
- 11-digit product format
- 729120535
- Labeler code
- 72912
- Product ID
- 72912-535_d5202e47-4f6c-423a-8f94-a8a5402da896
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- methylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Adlon Therapeutics L.P.
- Application
- NDA212038
- Marketing category
- NDA
- Marketing start
- 2019-07-01
- Marketing end
- 2023-11-01
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 35 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 72912-535 | 72912-535-30 | D | Discontinued by firm | 2026-08-17 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N212038-001 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | |
| N212038-002 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | |
| N212038-003 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | |
| N212038-004 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | |
| N212038-005 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | |
| N212038-006 | ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N212038-001 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-001 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-001 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-001 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-001 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-001 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-001 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-001 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-001 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-001 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-001 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-001 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | |
| N212038-002 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-002 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-002 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-002 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-002 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-002 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-002 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-002 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-002 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-002 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-002 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-002 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | |
| N212038-003 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-003 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-003 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-003 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-003 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-003 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-003 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-003 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-003 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-003 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-003 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-003 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | |
| N212038-004 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-004 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-004 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-004 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-004 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-004 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-004 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-004 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-004 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-004 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-004 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-004 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | |
| N212038-005 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-005 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-005 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-005 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-005 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-005 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-005 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-005 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-005 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-005 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-005 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-005 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | |
| N212038-006 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | |
| N212038-006 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | |
| N212038-006 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 |
| N212038-006 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | |
| N212038-006 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | |
| N212038-006 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | |
| N212038-006 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | |
| N212038-006 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | |
| N212038-006 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 |
| N212038-006 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | |
| N212038-006 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | |
| N212038-006 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 |
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 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-005 | ADHANSIA XR | 70MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N212038-006 | ADHANSIA XR | 85MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-001 | ADHANSIA XR | 25MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-002 | ADHANSIA XR | 35MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-003 | ADHANSIA XR | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-004 | ADHANSIA XR | 55MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-02-27 | 03ed91905a0d… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-001 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-002 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10500162 | 2035-10-30 | U-2357 | 2019-12-11 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10507186 | 2035-10-30 | Drug product | 2019-12-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10512612 | 2035-10-30 | Drug product | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10512613 | 2035-10-30 | U-2357 | 2020-01-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10568841 | 2035-10-30 | U-2357 | Drug product | 2020-02-26 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10688060 | 2035-10-30 | Drug product | 2020-06-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 9974752 | 2035-10-30 | Drug product | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-003 | 10722473 | 2038-11-19 | U-2357 | 2020-07-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-004 | 10111839 | 2035-10-30 | U-2357 | 2019-03-08 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-004 | 10292938 | 2035-10-30 | Drug product | 2019-05-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N212038-004 | 10292939 | 2035-10-30 | U-2357 | Drug product | 2019-05-22 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N212038-004 | 10449159 | 2035-10-30 | U-2357 | 2019-10-22 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-001 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-002 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-003 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-004 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-005 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N212038-006 | M-82 | 2024-06-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-001 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-002 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-003 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-004 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-005 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N212038-006 | M-82 | 2024-06-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-001 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-002 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-003 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-004 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-005 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N212038-006 | M-82 | 2024-06-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-001 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-002 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-003 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-004 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-005 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N212038-006 | M-82 | 2024-06-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-001 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-002 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-003 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-004 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-005 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N212038-006 | M-82 | 2024-06-28 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-001 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-002 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-003 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-004 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-005 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N212038-006 | M-82 | 2024-06-28 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212038-001 | M-82 | 2024-06-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212038-002 | M-82 | 2024-06-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212038-003 | M-82 | 2024-06-28 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N212038-004 | M-82 | 2024-06-28 | 301d65b070ca… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72912-535-30 | EA - Each | 72912-535 | da2bd3e2-c307-4265-af20-9b18d3ce279d | 1 | 2019-07-02 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72912-535-30 | 72912053530 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72912-535-30) | 2019-07-01 | 2023-11-01 | No | No | Current |