Quetiapine
- Product NDC
- 67046-0487
- 11-digit product format
- 670460487
- Labeler code
- 67046
- Product ID
- 67046-0487_5605249c-4e4c-8eb0-e063-6394a90a8145
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA201504
- Marketing category
- ANDA
- Marketing start
- 2026-07-07
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-004 | QUETIAPINE FUMARATE | EQ 150MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-005 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-006 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A201504-007 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2013-02-12 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A201504-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-006 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A201504-007 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A201504-007 | AB | 1 | caaa826d4ba7… |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S3PL1B6UJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312743 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 56052e5c-0b0b-c296-e063-6394a90a5ad6 | Available on FDA.report |
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 | Proficient Rx LP | 392dd5cf-4777-4985-b62b-7370134dee26 | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | ccacb909-8ee5-4223-bfee-9cfeae470ecf | 2023-11-24 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 85f973e0-93e6-4856-9266-62136acb2532 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | A-S Medication Solutions | 95156201-ed16-4806-98a7-d42acc902126 | 2023-06-15 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | c1f2ccba-62f3-44e7-b06f-dea61eac9e93 | 2023-04-01 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
| Quetiapine Fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 03517f29-f270-4350-a57a-fbe1967b0096 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 201504 ANDA201504 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 67046-0487-3 | 67046048703 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0487-3) | 2026-07-07 | No | No | Current |