Quetiapine
- Product NDC
- 63629-2482
- 11-digit product format
- 636292482
- Labeler code
- 63629
- Product ID
- 63629-2482_ecf5fa47-ee56-4197-b374-393c083e347d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA209635
- Marketing category
- ANDA
- Marketing start
- 2017-11-29
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- 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 | 63629-2482 | D | Discontinued by firm | 2026-08-10 | ||
| excluded package | package | 63629-2482 | 63629-2482-1 | D | Discontinued by firm | 2026-08-10 |
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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 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 | 63629-2482-1 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209635-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A209635-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A209635-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A209635-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A209635-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209635-001 | AB |
| A209635-002 | AB |
| A209635-003 | AB |
| A209635-004 | AB |
| A209635-005 | AB |
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 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-001 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-002 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-003 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-004 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-005 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-11-16 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A209635-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A209635-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209635-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A209635-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209635-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209635-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209635-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209635-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209635-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-2482-1 | EA - Each | 63629-2482 | 58dc01cc-8554-4788-9902-5f8ffbb0f6f6 | 1 | 2021-05-05 |
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 |
|---|---|---|---|---|---|---|
| Quetiapine Extended Release | QUETIAPINE | REMEDYREPACK INC. | 995731f7-aace-4140-b699-d6e8975c7c83 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Extended Release | QUETIAPINE | NuCare Pharmaceuticals, Inc. | 44e9b338-b163-bee7-e063-6394a90a1338 | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Extended Release | QUETIAPINE | Golden State Medical Supply, Inc. | 04cd529c-198b-5b85-e063-6294a90a4684 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Extended Release | QUETIAPINE | ST. MARY'S MEDICAL PARK PHARMACY | 3622cbd4-d7cb-57d4-e063-6294a90a5f24 | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Extended Release | QUETIAPINE | ScieGen Pharmaceuticals, Inc | 5e4a84b1-fb8c-44d0-8213-51e43d71db69 | 2025-02-01 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Fumarate ER | QUETIAPINE FUMARATE ER | Direct_Rx | 0917ef53-2647-b54b-e063-6294a90a4211 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Fumarate ER | QUETIAPINE FUMARATE ER | Direct_rx | 23820efc-4df7-9dc9-e063-6394a90a0bb4 | 2024-10-02 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
| Quetiapine Extended Release | QUETIAPINE | ACI Healthcare USA, Inc. | 07e4f3f4-42cb-4b22-bf8d-8c3279d26e97 | 2021-01-28 | Boxed warning, Warnings, Adverse reactions | 209635 ANDA209635 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-2482-1 | 63629248201 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-2482-1) | 2021-03-08 | 0000-00-00 | No | No | Current |