Quetiapine Fumarate
- Product NDC
- 70518-0975
- Requested package NDC
- 70518-0975-0
- 11-digit product format
- 705180975
- Labeler code
- 70518
- Product ID
- 70518-0975_e2acc6bd-ad2f-1400-e053-2a95a90a2237
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine Fumarate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2018-01-22
- Marketing end
- 0000-00-00
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 200 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 package | package | 70518-0975 | 70518-0975-0 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201504-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | |
| A201504-007 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201504-001 | AB |
| A201504-002 | AB |
| A201504-003 | AB |
| A201504-004 | AB |
| A201504-005 | AB |
| A201504-006 | AB |
| A201504-007 | 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 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201504-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201504-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201504-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201504-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201504-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-006 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201504-007 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201504-005 | AB | 1 | 03ed91905a0d… |
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 | QUETIAPINE | Coupler LLC | 56052e5c-0b0b-c296-e063-6394a90a5ad6 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | NuCare Pharmaceuticals,Inc. | 16f48034-b8c9-ab2b-e063-6294a90adf65 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | f6de1d2b-b10e-2e9a-e053-6394a90a735d | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | Cardinal Health 107, LLC | 32bc1ecb-7285-4013-b266-ca783a62d617 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | Major Pharmaceuticals | f9447739-9e21-4232-950f-174c0496ab66 | 2026-01-02 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE | A-S Medication Solutions | 10288afa-c4dc-4897-9ec8-f4573d850779 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | AvPAK | 6b7d7d2f-a50b-8e21-2de4-ccc102016384 | 2025-12-16 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | ASCLEMED USA INC. | 74e09734-26cb-42fe-b9a3-79cc10505e0b | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 717b55c4-a23f-4d74-8023-0f4e14d89ec8 | 2025-09-17 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | REMEDYREPACK INC. | b7aa0fce-1406-4665-a791-e30aed7b24ff | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | Bryant Ranch Prepack | 01261008-5f42-4844-8a65-d4545a67a309 | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | f75a4d38-ea0e-4780-abf2-67672894a11b | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct_Rx | e4ce9d50-9786-2233-e053-2a95a90a276f | 2025-06-16 | Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | Ascend Laboratories, LLC | 3112a006-1c61-47f2-84f5-9a7670d09c9b | 2025-05-21 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 6efc2886-7dcc-4dac-a212-76078a7efaa7 | 2025-05-14 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 45947f72-d870-4f6e-9e5f-38d6b324d5fe | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 35b2069e-209a-41ac-84e6-377d4f19be87 | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine | QUETIAPINE | PD-Rx Pharmaceuticals, Inc. | da3c9642-9f8d-422b-8e12-2036d68f78ca | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Preferred Pharmaceuticals Inc. | 69275af7-1469-4405-a98e-e8b0f8d42dd9 | 2025-02-10 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Direct Rx | db48ec02-1119-f343-e053-2a95a90afb3b | 2025-01-22 | Warnings, Adverse reactions | 201504 ANDA201504 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-0975-0 | 70518097500 | 30 TABLET in 1 BLISTER PACK (70518-0975-0) | 30 tablet | 2018-01-22 | 0000-00-00 | No | No | Current |