Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Product NDC
- 0555-0790
- 11-digit product format
- 005550790
- Labeler code
- 0555
- Product ID
- 0555-0790_2ead3340-41f0-43ab-9eb5-53825534fb19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Barr Laboratories Inc.
- Application
- NDA021303
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2009-04-02
- Marketing end
- 2020-07-31
- Substance
- DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
- Active strength
- 1 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],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 product | product | 0555-0790 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0555-0790 | 0555-0790-02 | D | Discontinued by firm | 2026-08-11 |
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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 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 | 0555-0790-02 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021303-001 | ADDERALL XR 10 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 |
| N021303-002 | ADDERALL XR 20 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 |
| N021303-003 | ADDERALL XR 30 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 |
| N021303-004 | ADDERALL XR 25 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
| N021303-005 | ADDERALL XR 5 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
| N021303-006 | ADDERALL XR 15 | AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021303-001 | AB1 |
| N021303-002 | AB1 |
| N021303-003 | AB1 |
| N021303-004 | AB1 |
| N021303-005 | AB1 |
| N021303-006 | AB1 |
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 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-005 | ADDERALL XR 5 | 1.25MG;1.25MG;1.25MG;1.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-006 | ADDERALL XR 15 | 3.75MG;3.75MG;3.75MG;3.75MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-001 | ADDERALL XR 10 | 2.5MG;2.5MG;2.5MG;2.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-002 | ADDERALL XR 20 | 5MG;5MG;5MG;5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2001-10-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-003 | ADDERALL XR 30 | 7.5MG;7.5MG;7.5MG;7.5MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD, RS | 2001-10-11 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-004 | ADDERALL XR 25 | 6.25MG;6.25MG;6.25MG;6.25MG | CAPSULE, EXTENDED RELEASE / ORAL | AB1 | RLD | 2002-05-22 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021303-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-002 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-003 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-004 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-005 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021303-006 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-003 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-004 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-005 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021303-006 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-003 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-004 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-005 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021303-006 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-002 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-003 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-004 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-005 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021303-006 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-003 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-004 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-005 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021303-006 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-002 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-003 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-004 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-005 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021303-006 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-003 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021303-004 | AB1 | 1 | 2680178bc6a6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-001 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-002 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-003 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-004 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-005 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | 6322819*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | 6605300*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | RE41148*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021303-006 | RE42096*PED | 2019-04-21 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-001 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-002 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-003 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | 6322819*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | 6605300*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | RE41148*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021303-004 | RE42096*PED | 2019-04-21 | Pediatric extension | 3f01610625f2… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0555-0790-02 | EA - Each | 0555-0790 | 43967101-b332-4e73-b01e-642b75070885 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Adderall XR | DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE | Takeda Pharmaceuticals America, Inc. | aff45863-ffe1-4d4f-8acf-c7081512a6c0 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 021303 NDA021303 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Sandoz Inc | 6f637e8d-7c2e-47fa-a43c-3250c51aed77 | 2023-10-13 | Boxed warning, Warnings, Adverse reactions | 021303 NDA021303 |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE | Prasco Laboratories | f85af6ee-9029-42de-adea-6dbb8642952c | 2023-10-13 | Boxed warning, Warnings, Adverse reactions | 021303 NDA021303 |