Quetiapine fumarate
- Product NDC
- 63187-269
- 11-digit product format
- 631870269
- Labeler code
- 63187
- Product ID
- 63187-269_2fb97f0d-ad18-445a-b9a5-f128ae90cfc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA202152
- Marketing category
- ANDA
- Marketing start
- 2012-03-26
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 100 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 |
|---|---|---|---|---|---|---|---|
| A202152-001 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-002 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-003 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-004 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-005 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | |
| A202152-006 | QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202152-001 | AB |
| A202152-002 | AB |
| A202152-003 | AB |
| A202152-004 | AB |
| A202152-005 | AB |
| A202152-006 | 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 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-005 | QUETIAPINE FUMARATE | EQ 300MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-006 | QUETIAPINE FUMARATE | EQ 400MG BASE | TABLET / ORAL | AB | 2012-03-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-001 | QUETIAPINE FUMARATE | EQ 25MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-002 | QUETIAPINE FUMARATE | EQ 50MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-003 | QUETIAPINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-004 | QUETIAPINE FUMARATE | EQ 200MG BASE | TABLET / ORAL | AB | 2012-03-27 | 2680178bc6a6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A202152-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202152-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202152-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202152-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202152-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-005 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202152-006 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-005 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202152-006 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202152-004 | AB | 1 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine fumarate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| QUETIAPINE FUMARATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S3PL1B6UJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | Available on FDA.report |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63187-269-30 | Quetiapine fumarate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 7 | |
| 63187-269-60 | Quetiapine fumarate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 7 | |
| 63187-269-90 | Quetiapine fumarate | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Bryant Ranch Prepack | cb989abf-7d73-4ab9-a07f-a8c9de50389f | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | a45d8b77-f13d-41c5-8d50-15152fc6f85c | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| QUETIAPINE FUMARATE | QUETIAPINE FUMARATE | Bryant Ranch Prepack | 45c4c3a4-3acc-413e-9746-4816d513fac6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| Quetiapine | QUETIAPINE | Accord Healthcare Inc. | 2d77412a-e084-4406-ac33-d882aece9354 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| Quetiapine | QUETIAPINE | Proficient Rx LP | 7a090720-fd90-4976-9aa2-41812106eb70 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 1a147d6c-8af8-4379-8a13-1864a9a79b84 | 2022-10-01 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 |
| Quetiapine fumarate | QUETIAPINE FUMARATE | Proficient Rx LP | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 202152 ANDA202152 63187-269 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312743 | QUEtiapine fumarate 100 MG Oral Tablet | PSN | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
| 616487 | QUEtiapine fumarate 50 MG Oral Tablet | PSN | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
| 312743 | quetiapine 100 MG Oral Tablet | SCD | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
| 616487 | quetiapine 50 MG Oral Tablet | SCD | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
| 312743 | quetiapine (as quetiapine fumarate) 100 MG Oral Tablet | SY | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
| 616487 | quetiapine (as quetiapine fumarate) 50 MG Oral Tablet | SY | 8048ac0a-5d4d-4d00-ab9c-7fcac27f0a60 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63187-269-30 | 63187026930 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-269-30) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-269-60 | 63187026960 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-269-60) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-269-90 | 63187026990 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-269-90) | 2014-09-01 | 0000-00-00 | No | No | Current |