Adzenys XR-ODT
- Product NDC
- 70165-030
- 11-digit product format
- 701650030
- Labeler code
- 70165
- Product ID
- 70165-030_51b6449e-77c9-3dac-e063-6294a90aaeb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amphetamine
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Neos Therapeutics Brands, LLC
- Application
- NDA204326
- Marketing category
- NDA
- Marketing start
- 2016-02-16
- Substance
- AMPHETAMINE
- Active strength
- 18.8 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204326-001 | ADZENYS XR-ODT | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 |
| N204326-002 | ADZENYS XR-ODT | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 |
| N204326-003 | ADZENYS XR-ODT | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 |
| N204326-004 | ADZENYS XR-ODT | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 |
| N204326-005 | ADZENYS XR-ODT | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 |
| N204326-006 | ADZENYS XR-ODT | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N204326-001 | AB |
| N204326-002 | AB |
| N204326-003 | AB |
| N204326-004 | AB |
| N204326-005 | AB |
| N204326-006 | AB |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204326-001 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-001 | 8709491 | 2032-06-28 | Drug product | 2016-02-26 | |
| N204326-001 | 9017731 | 2032-06-28 | Drug product | 2016-02-26 | |
| N204326-001 | 9265737 | 2032-06-28 | Drug product | 2016-02-26 | |
| N204326-001 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | |
| N204326-002 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-002 | 8709491 | 2032-06-28 | Drug product | ||
| N204326-002 | 9017731 | 2032-06-28 | Drug product | ||
| N204326-002 | 9265737 | 2032-06-28 | Drug product | ||
| N204326-002 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | |
| N204326-003 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-003 | 8709491 | 2032-06-28 | Drug product | ||
| N204326-003 | 9017731 | 2032-06-28 | Drug product | ||
| N204326-003 | 9265737 | 2032-06-28 | Drug product | ||
| N204326-003 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | |
| N204326-004 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-004 | 8709491 | 2032-06-28 | Drug product | ||
| N204326-004 | 9017731 | 2032-06-28 | Drug product | ||
| N204326-004 | 9265737 | 2032-06-28 | Drug product | ||
| N204326-004 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | |
| N204326-005 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-005 | 8709491 | 2032-06-28 | Drug product | ||
| N204326-005 | 9017731 | 2032-06-28 | Drug product | ||
| N204326-005 | 9265737 | 2032-06-28 | Drug product | ||
| N204326-005 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | |
| N204326-006 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | |
| N204326-006 | 8709491 | 2032-06-28 | Drug product | ||
| N204326-006 | 9017731 | 2032-06-28 | Drug product | ||
| N204326-006 | 9265737 | 2032-06-28 | Drug product | ||
| N204326-006 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 |
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 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD | 2016-01-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | AB | RLD, RS | 2016-01-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-005 | ADZENYS XR-ODT | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204326-006 | ADZENYS XR-ODT | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD, RS | 2016-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204326-001 | ADZENYS XR-ODT | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204326-002 | ADZENYS XR-ODT | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204326-003 | ADZENYS XR-ODT | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204326-004 | ADZENYS XR-ODT | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE / ORAL | RLD | 2016-01-27 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204326-005 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204326-006 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-002 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-003 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-004 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-005 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204326-006 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-004 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-005 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204326-006 | AB | 1 | a67488948f0b… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-005 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N204326-006 | AB | 1 | a50c72e98297… |
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 | N204326-001 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-001 | 8709491 | 2032-06-28 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-001 | 9017731 | 2032-06-28 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-001 | 9265737 | 2032-06-28 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-001 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | 8709491 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | 9017731 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | 9265737 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-002 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | 8709491 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | 9017731 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | 9265737 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-003 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | 8709491 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | 9017731 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | 9265737 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-004 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | 8709491 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | 9017731 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | 9265737 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-005 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | 8709491 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | 9017731 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | 9265737 | 2032-06-28 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N204326-006 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | 8709491 | 2032-06-28 | Drug product | 2016-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | 9017731 | 2032-06-28 | Drug product | 2016-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | 9265737 | 2032-06-28 | Drug product | 2016-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-001 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | 8840924 | 2026-04-09 | Drug product | 2016-02-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | 8709491 | 2032-06-28 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | 9017731 | 2032-06-28 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | 9265737 | 2032-06-28 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N204326-002 | 9839619 | 2032-06-28 | Drug product | 2024-04-22 | caaa826d4ba7… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Adzenys XR-ODT
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AMPHETAMINE | 18.8 mg/1 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0f66b30d-6b15-4b2d-91a5-1531b9bb6d21 | Product name | 7 | 20250625 |
| 917bdf48-c3f5-4a58-ac8e-d2d94a9c1e2b | Product name | 2 | 20250616 |
| 8b92ab59-8b26-4c89-a2d6-8d5140526ec6 | Product name | 3 | 20231213 |
| 4496d022-9224-4ee0-943a-50fbe6cd7123 | Product name | 2 | 20220901 |
| 2a7aa275-a4ca-44eb-971f-47427a374085 | Product name | 9 | 20220615 |
| 93730fbf-8b45-4623-b27d-cf03825d04b3 | Product name | 5 | 20220314 |
| a90f088a-9578-47a2-8f6e-0a9d32aafec6 | Product name | 1 | 20181030 |
| f6c90bdc-1674-455a-aadd-1b1b59e5edeb | Product name | 2 | 20181030 |
| 57953747-955c-4dd8-9164-49d8ea877eae | Product name | 1 | 20171113 |
| fcc7ea58-a369-4e91-b092-5cde9ac2669f | Product name | 1 | 20160224 |
| f1ec5c2f-d01e-a277-5826-c7eba86ed99b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70165-030-30 | Adzenys XR-ODT | 30 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 30 | 15 | |
| 70165-030-30 | Adzenys XR-ODT | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70165-030-30 | EA - Each | 70165-030 | 7f02a7b1-6882-4946-ac87-f7f88f81afa7 | 1 | 2016-04-04 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1739809 | Adzenys XR-ODT 12.5 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739815 | Adzenys XR-ODT 15.7 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739821 | Adzenys XR-ODT 18.8 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739827 | Adzenys XR-ODT 3.1 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739833 | Adzenys XR-ODT 6.3 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739839 | Adzenys XR-ODT 9.4 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739803 | amphetamine 12.5 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739813 | amphetamine 15.7 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739819 | amphetamine 18.8 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739825 | amphetamine 3.1 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739831 | amphetamine 6.3 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739837 | amphetamine 9.4 MG 24HR Extended Release Distintegrating Oral Tablet | PSN | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739809 | 24 HR amphetamine 12.5 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739815 | 24 HR amphetamine 15.7 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739821 | 24 HR amphetamine 18.8 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739827 | 24 HR amphetamine 3.1 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739833 | 24 HR amphetamine 6.3 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739839 | 24 HR amphetamine 9.4 MG Extended Release Oral Tablet [Adzenys] | SBD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739803 | 24 HR amphetamine 12.5 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739813 | 24 HR amphetamine 15.7 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739819 | 24 HR amphetamine 18.8 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739825 | 24 HR amphetamine 3.1 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739831 | 24 HR amphetamine 6.3 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739837 | 24 HR amphetamine 9.4 MG Extended Release Oral Tablet | SCD | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739809 | Adzenys 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739815 | Adzenys 15.7 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739821 | Adzenys 18.8 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739827 | Adzenys 3.1 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739833 | Adzenys 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739839 | Adzenys 9.4 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739803 | amphetamine 12.5 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739813 | amphetamine 15.7 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739819 | amphetamine 18.8 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739825 | amphetamine 3.1 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739831 | amphetamine 6.3 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
| 1739837 | amphetamine 9.4 MG 24 HR Extended Release Distintegrating Oral Tablet | SY | c1179269-00b5-48ea-972d-31e614e99b7e | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70165-030-30 | 70165003030 | 30 BLISTER PACK in 1 CARTON (70165-030-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 30 blister pack | 2016-02-16 | 0000-00-00 | No | No | Current |
| 70165-030-31 | 70165003031 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (70165-030-31) | 2026-10-01 | No | No | Current |