Olanzapine

Product NDC
55154-5896
11-digit product format
551545896
Labeler code
55154
Product ID
55154-5896_7d0235dc-b4e8-4f39-a877-4f547c67a9cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076255
Marketing category
ANDA
Marketing start
2012-04-23
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
3 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.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-5896DDiscontinued by firm2026-08-03
excluded packagepackage55154-589655154-5896-0DDiscontinued by firm2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct55154-5896DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-589655154-5896-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076255-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2012-04-23
A076255-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2012-04-23
A076255-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2012-04-23
A076255-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2012-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076255-001AB
A076255-002AB
A076255-003AB
A076255-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076255-001OLANZAPINE2.5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-002OLANZAPINE5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-003OLANZAPINE7.5MGTABLET / ORALAB2012-04-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-004OLANZAPINE10MGTABLET / ORALAB2012-04-23d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076255-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076255-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076255-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076255-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076255-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076255-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076255-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076255-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076255-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076255-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076255-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076255-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076255-004AB1d06236e962d9…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5896OLANZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]9Legacy NDC20241122_120b31d1-4d56-4f28-8a90-dfcb9ad78d9c.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 · 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEREMEDYREPACK INC.2a7300d3-95e3-427e-bf37-55fa654cc90a2026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.3d69af75-7615-4ec2-b7ef-467b2558c5c82026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.b513823d-927c-4111-8766-e6c37f84b2212026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.68de2a51-69b2-4d99-be79-36a95a4bc4752026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEMajor Pharmaceuticals0ecbf540-572e-4ca4-b694-18ca1cd1c1942026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55669a10-93f3-cfd6-e063-6294a90aa0e62026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEUnit Dose Solutions, Inc.55668be2-62ac-3252-e063-6394a90a40f72026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC53e6b4e9-de26-16c3-e063-6294a90a77642026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC52b99337-afa8-a6f9-e063-6294a90a20382026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECoupler LLC51b64b6d-4676-a637-e063-6394a90a450c2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEDr. Reddy's Laboratories Inc.d474d5a9-d338-511d-5823-567c0a1bbf4d2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINECardinal Health 107, LLC38a89689-efc2-4931-8f65-868dc0248d6a2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEREMEDYREPACK INC.dc56c264-d10e-4059-b0d5-2feff16b345d2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEAmerican Health Packaging75616c31-8fed-4014-a9f2-4a028eccd5862025-10-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.cfc0f187-d3ff-4bbb-9129-0e94c6eda0ee2025-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.d349d5b7-5658-46d6-9bba-e6f6361cebb92025-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.10043041-a632-4e57-bc08-37216dea85462025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEBryant Ranch Prepack3c9963b1-c498-48a0-a3a1-1eaa6a1028fc2025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEBryant Ranch Prepack09e48e71-4dd2-4538-91d7-5b284f6647d82023-03-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255
OlanzapineOLANZAPINEDr. Reddy's Laboratories Ltd.9a57a63e-f856-aafa-037a-c08f2fea64962022-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076255
application number: ANDA076255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5896-05515458960010 BLISTER PACK in 1 BAG (55154-5896-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2012-04-230000-00-00NoNoCurrent