Quetiapine

Product NDC
16729-147
11-digit product format
167290147
Labeler code
16729
Product ID
16729-147_438f950d-730b-8926-e063-6294a90a8f66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202152
Marketing category
ANDA
Marketing start
2012-03-28
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

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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct16729-147UNFINISHEDActive or certified unfinished drug listing2026-08-03
unfinished packagepackage16729-14716729-147-22UNFINISHEDActive or certified unfinished drug listing2026-08-03

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.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage16729-147-22a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage16729-147-221d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage16729-147-22390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage16729-147-22e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage16729-147-22bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage16729-147-22f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage16729-147-22f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage16729-147-2268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage16729-147-2205c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage16729-147-2248b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage16729-147-2227f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage16729-147-228d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage16729-147-22d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage16729-147-2250b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage16729-147-22906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage16729-147-226db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage16729-147-228fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage16729-147-224184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage16729-147-224bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage16729-147-22263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage16729-147-225b2001dcd8f5…54b53d4dc9e4…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202152-001QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27
A202152-002QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27
A202152-003QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27
A202152-004QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27
A202152-005QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27
A202152-006QUETIAPINE FUMARATEQUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A202152-001AB
A202152-002AB
A202152-003AB
A202152-004AB
A202152-005AB
A202152-006AB

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.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-005QUETIAPINE FUMARATEEQ 300MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-006QUETIAPINE FUMARATEEQ 400MG BASETABLET / ORALAB2012-03-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-001QUETIAPINE FUMARATEEQ 25MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-002QUETIAPINE FUMARATEEQ 50MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-003QUETIAPINE FUMARATEEQ 100MG BASETABLET / ORALAB2012-03-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-004QUETIAPINE FUMARATEEQ 200MG BASETABLET / ORALAB2012-03-272680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202152-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202152-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202152-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202152-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202152-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202152-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202152-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202152-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202152-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Quetiapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
QUETIAPINE FUMARATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2S3PL1B6UJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312743Internal RxNorm lookup
312744Internal RxNorm lookup
312745Internal RxNorm lookup
317174Internal RxNorm lookup
616483Internal RxNorm lookup
616487Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d77412a-e084-4406-ac33-d882aece9354Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ef42f82-f087-0d2c-105f-f791ca69210eProduct name820250729
21205abd-8c89-4943-9f85-908f3d4fc3bbProduct name520230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-147-01Quetiapine100 in 1 BOTTLETABLET, FILM COATED10017
16729-147-10Quetiapine30 in 1 BOTTLETABLET, FILM COATED3017
16729-147-17Quetiapine1000 in 1 BOTTLETABLET, FILM COATED100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-147-01EA - Each16729-147e82537dd-1244-4d89-945f-90fd9f40d8fa12012-07-24
16729-147-10EA - Each16729-147df679c0f-106a-4d70-986d-edc23ff9c1d012013-02-13
16729-147-17EA - Each16729-147300a6657-60ec-4357-89ec-a3d550cb059712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]5
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [UNIT DOSE SERVICES]3
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
QUETIAPINE FUMARATEACTIVE INGREDIENT2S3PL1B6UJQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
QUETIAPINEACTIVE MOIETYBGL0JSY5SIQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2QUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUETIAPINE FUMARATE TABLET, FILM COATED [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-147QUETIAPINE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]16Current NDC, Legacy NDC, 3 package rows20240719_2d77412a-e084-4406-ac33-d882aece9354.zip

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.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QuetiapineQUETIAPINEBryant Ranch Prepackcb989abf-7d73-4ab9-a07f-a8c9de50389f2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepacka45d8b77-f13d-41c5-8d50-15152fc6f85c2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack4e1e5249-1cb7-4cc2-ad5a-cdeeee2f494f2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QUETIAPINE FUMARATEQUETIAPINE FUMARATEBryant Ranch Prepack45c4c3a4-3acc-413e-9746-4816d513fac62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
QuetiapineQUETIAPINEAccord Healthcare Inc.2d77412a-e084-4406-ac33-d882aece93542025-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
ndc (product): 16729-147
QuetiapineQUETIAPINEProficient Rx LP7a090720-fd90-4976-9aa2-41812106eb702022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP1a147d6c-8af8-4379-8a13-1864a9a79b842022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152
Quetiapine fumarateQUETIAPINE FUMARATEProficient Rx LP8048ac0a-5d4d-4d00-ab9c-7fcac27f0a602022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202152
application number: ANDA202152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312743QUEtiapine fumarate 100 MG Oral TabletPSN45c4c3a4-3acc-413e-9746-4816d513fac61006
312743quetiapine 100 MG Oral TabletSCD45c4c3a4-3acc-413e-9746-4816d513fac61006
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY45c4c3a4-3acc-413e-9746-4816d513fac61006
312743QUEtiapine fumarate 100 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
317174QUEtiapine fumarate 200 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312744QUEtiapine fumarate 25 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312745QUEtiapine fumarate 300 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616483QUEtiapine fumarate 400 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
616487QUEtiapine fumarate 50 MG Oral TabletPSN2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine 100 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine 200 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine 25 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine 300 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine 400 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine 50 MG Oral TabletSCD2d77412a-e084-4406-ac33-d882aece935417
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616483quetiapine (as quetiapine fumarate) 400 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY2d77412a-e084-4406-ac33-d882aece935417
312743QUEtiapine fumarate 100 MG Oral TabletPSN8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487QUEtiapine fumarate 50 MG Oral TabletPSN8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743quetiapine 100 MG Oral TabletSCD8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487quetiapine 50 MG Oral TabletSCD8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
616487quetiapine (as quetiapine fumarate) 50 MG Oral TabletSY8048ac0a-5d4d-4d00-ab9c-7fcac27f0a607
312743QUEtiapine fumarate 100 MG Oral TabletPSN5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743QUEtiapine fumarate 100 MG Oral TabletPSNc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312744QUEtiapine fumarate 25 MG Oral TabletPSN5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743quetiapine 100 MG Oral TabletSCDc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312743quetiapine 100 MG Oral TabletSCD5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312744quetiapine 25 MG Oral TabletSCD5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSYc20c80f1-9e68-4db1-9158-e9be9b7dc4bf6
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312744quetiapine (as quetiapine fumarate) 25 MG Oral TabletSY5dd65e85-430b-4e25-bfe0-5b4c332c39c06
312743QUEtiapine fumarate 100 MG Oral TabletPSN18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743quetiapine 100 MG Oral TabletSCD18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY18d1ee40-b529-43d6-b0dc-30ee47d9c33a2
312743QUEtiapine fumarate 100 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174QUEtiapine fumarate 200 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745QUEtiapine fumarate 300 MG Oral TabletPSN5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine 100 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine 200 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine 300 MG Oral TabletSCD5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312743quetiapine (as quetiapine fumarate) 100 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
317174quetiapine (as quetiapine fumarate) 200 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71
312745quetiapine (as quetiapine fumarate) 300 MG Oral TabletSY5a1a6ce6-741d-6941-e053-2a91aa0a83e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-147-0116729014701100 TABLET, FILM COATED in 1 BOTTLE (16729-147-01) 2012-03-280000-00-00NoNoCurrent
16729-147-101672901471030 in 1 BOTTLEHistorical
16729-147-17167290147171000 TABLET, FILM COATED in 1 BOTTLE (16729-147-17) 2012-03-280000-00-00NoNoCurrent
16729-147-22167290147225000 TABLET, FILM COATED in 1 CONTAINER (16729-147-22)16-DEC-15Current