Quetiapine Fumarate
- Product NDC
- 34908-639
- 11-digit product format
- 349080639
- Labeler code
- 34908
- Product ID
- 34908-639_781f6242-bc94-424b-be23-ea9eb61c0889
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- quetiapine fumarate
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Novast Laboratories, Ltd.
- Application
- ANDA208947
- Marketing category
- ANDA
- Marketing start
- 2017-08-31
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208947-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A208947-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A208947-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A208947-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | |
| A208947-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208947-001 | AB |
| A208947-002 | AB |
| A208947-003 | AB |
| A208947-004 | AB |
| A208947-005 | 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 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-002 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-003 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-004 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-001 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-002 | 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 | A208947-003 | 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 | A208947-004 | 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 | A208947-005 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET, EXTENDED RELEASE / ORAL | AB | 2017-11-29 | 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 | A208947-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208947-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208947-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208947-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208947-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208947-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208947-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208947-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208947-005 | AB | 1 | 5bbf6a4d5a75… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine Fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 400 mg/1 |
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 Fumarate | QUETIAPINE FUMARATE | Ingenus Pharmaceuticals, LLC | 8923c441-c9aa-4b30-89d7-dbaaa7f66656 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 208947 ANDA208947 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 34908-639-10 | 34908063910 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-10) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-639-30 | 34908063930 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-30) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-639-60 | 34908063960 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-60) | 2017-08-31 | 0000-00-00 | No | No | Current |
| 34908-639-90 | 34908063990 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-90) | 2017-08-31 | 0000-00-00 | No | No | Current |