Quetiapine Fumarate
- Product NDC
- 0406-1184
- 11-digit product format
- 004061184
- Labeler code
- 0406
- Product ID
- 0406-1184_9bca76f4-2922-4b22-a6f6-d65a10dc6a84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- ANDA202939
- Marketing category
- ANDA
- Marketing start
- 2017-05-15
- 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
- 2020-12-31
- 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 | 0406-1184 | I | Inactivated by FDA | 2026-08-03 | ||
| excluded package | package | 0406-1184 | 0406-1184-60 | I | Inactivated by FDA | 2026-08-03 |
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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 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 | 0406-1184-60 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 0406-1184-60 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 0406-1184-60 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 0406-1184-60 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0406-1184-60 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0406-1184-60 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0406-1184-60 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0406-1184-60 | 8dfbde2a14a4… | c9ff85d89658… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202939-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | |
| A202939-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | |
| A202939-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | |
| A202939-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | |
| A202939-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202939-001 | AB |
| A202939-002 | AB |
| A202939-003 | AB |
| A202939-004 | AB |
| A202939-005 | 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 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-05-09 | 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 | A202939-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202939-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202939-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202939-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202939-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202939-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202939-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202939-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202939-005 | AB | 1 | 5bbf6a4d5a75… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5ef42f82-f087-0d2c-105f-f791ca69210e | Product name | 8 | 20250729 |
| 21205abd-8c89-4943-9f85-908f3d4fc3bb | Product name | 5 | 20230501 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0406-1184-60 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4812-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for QUETIAPINE FUMARATE EXTENDED-RELEASE TABLETS. QUETIAPINE FUMARATE extended-release tablets, for oral use Initial U.S. Approval: 1997 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0406-1184-60 | Quetiapine FumarateExtended-Release | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0406-1184-60 | EA - Each | 0406-1184 | 9d01d5a6-f6da-4130-be48-73402b4eb089 | 1 | 2017-06-15 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 895670 | QUEtiapine fumarate 150 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | QUEtiapine fumarate 300 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | QUEtiapine fumarate 400 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | QUEtiapine fumarate 50 MG 24HR Extended Release Oral Tablet | PSN | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | 24 HR quetiapine 150 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | 24 HR quetiapine 200 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | 24 HR quetiapine 300 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | 24 HR quetiapine 400 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | 24 HR quetiapine 50 MG Extended Release Oral Tablet | SCD | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | quetiapine 150 MG (as quetiapine fumarate 173 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 895670 | quetiapine 150 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721791 | quetiapine 200 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | quetiapine 300 MG (as quetiapine fumarate 345 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721794 | quetiapine 300 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 721796 | quetiapine 400 MG (as quetiapine fumarate 461 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | quetiapine 50 MG (as quetiapine fumarate 58 MG) 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
| 853201 | quetiapine 50 MG 24 HR Extended Release Oral Tablet | SY | b56d057a-f5d9-4919-a0f2-b96a76ff83b7 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 0406-1184-60 | 00406118460 | 60 in 1 BOTTLE | Historical |