Olanzapine

Product NDC
63187-340
11-digit product format
631870340
Labeler code
63187
Product ID
63187-340_c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202862-001OLANZAPINEOLANZAPINE2.5MGTABLET / ORALAB2014-08-15
A202862-002OLANZAPINEOLANZAPINE5MGTABLET / ORALAB2014-08-15
A202862-003OLANZAPINEOLANZAPINE7.5MGTABLET / ORALAB2014-08-15
A202862-004OLANZAPINEOLANZAPINE10MGTABLET / ORALAB2014-08-15
A202862-005OLANZAPINEOLANZAPINE15MGTABLET / ORALAB2014-08-15
A202862-006OLANZAPINEOLANZAPINE20MGTABLET / ORALAB2014-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202862-001AB
A202862-002AB
A202862-003AB
A202862-004AB
A202862-005AB
A202862-006AB

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 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-005OLANZAPINE15MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-006OLANZAPINE20MGTABLET / ORALAB2014-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-001OLANZAPINE2.5MGTABLET / ORALAB2014-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-002OLANZAPINE5MGTABLET / ORALAB2014-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-003OLANZAPINE7.5MGTABLET / ORALAB2014-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-004OLANZAPINE10MGTABLET / ORALAB2014-08-1503ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202862-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-005AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202862-006AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202862-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202862-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202862-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202862-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202862-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202862-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202862-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202862-004AB103ed91905a0d…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N7U69T4SZRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312078Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ce66d545-015b-41d5-80c3-964d78e36bfdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-340-06Olanzapine6 in 1 BOTTLETABLET, FILM COATED65
63187-340-30Olanzapine30 in 1 BOTTLETABLET, FILM COATED305
63187-340-60Olanzapine60 in 1 BOTTLETABLET, FILM COATED605
63187-340-90Olanzapine90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-340OLANZAPINE TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 4 package rows20230225_ce66d545-015b-41d5-80c3-964d78e36bfd.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEPreferred Pharmaceuticals Inc.5bded04a-d848-4ac6-b7c3-ff9b9fef3d292026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEREMEDYREPACK INC.9eb6b0d1-b301-4847-88f5-f8613d550ecc2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEPD-Rx Pharmaceuticals, Inc.b6f0b2e2-3cbd-4564-8b3e-f811589af2752026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEREMEDYREPACK INC.8e5ef52d-315b-4055-9e52-403e6f896f242026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINERedpharm Drug54adae9e-6781-6a77-e063-6394a90ab5c82026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINECoupler LLC549dc142-adcd-99ed-e063-6294a90a37fa2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINECoupler LLC52bdaaaf-ab54-99d1-e063-6394a90a521f2026-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINECoupler LLC518a9400-edb8-6403-e063-6294a90a065d2026-05-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEREMEDYREPACK INC.76a6ff21-7157-4213-8073-35837a3ac07e2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limited8e095987-bdea-42f2-9550-c7155cf07d302026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEREMEDYREPACK INC.88edb3fc-fcb6-4483-859d-f830b077aca22026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEBryant Ranch Prepackf6fd7ceb-1457-4c3e-9d30-4f658f39d37d2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEBryant Ranch Prepackc47f90fc-49fe-4f60-9da8-1365a1650dd92025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEBryant Ranch Prepackdcf8fcbf-636c-41ad-8084-c65ac2f117cc2025-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEBryant Ranch Prepack8586e828-34e7-4eb4-a933-6c688927478f2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINENCS HealthCare of KY, LLC dba Vangard Labs87b7fb23-c9b7-433f-bd17-cd3e91714c272025-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEDirect_Rxfcec190f-b865-c5d3-e053-6394a90a7e452025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEDirect_Rx22528ae1-e36f-48e1-e063-6294a90a3dd22024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINENorthStar RxLLCea3259d5-36ee-4ac9-b849-9625626e21872024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
OlanzapineOLANZAPINEProficient Rx LPce66d545-015b-41d5-80c3-964d78e36bfd2023-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202862
application number: ANDA202862
ndc (product): 63187-340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSNce66d545-015b-41d5-80c3-964d78e36bfd5
312078olanzapine 5 MG Oral TabletSCDce66d545-015b-41d5-80c3-964d78e36bfd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-340-06631870340066 TABLET, FILM COATED in 1 BOTTLE (63187-340-06) 2023-02-21NoNoCurrent
63187-340-306318703403030 TABLET, FILM COATED in 1 BOTTLE (63187-340-30) 2015-02-020000-00-00NoNoCurrent
63187-340-606318703406060 TABLET, FILM COATED in 1 BOTTLE (63187-340-60) 2023-02-21NoNoCurrent
63187-340-906318703409090 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) 2023-02-21NoNoCurrent