Olanzapine

Product NDC
59746-307
11-digit product format
597460307
Labeler code
59746
Product ID
59746-307_fddf60eb-156f-4e8c-9bad-3942d714fdce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA200221
Marketing category
ANDA
Marketing start
2012-09-13
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage59746-307-32ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage59746-307-32367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage59746-307-32557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage59746-307-328af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage59746-307-32834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage59746-307-321332a3947898…d4bfe170f9cd…

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
A200221-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12
A200221-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12
A200221-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12
A200221-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200221-001AB
A200221-002AB
A200221-003AB
A200221-004AB

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 UTC2026-02A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200221-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2012-09-12d06236e962d9…

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 UTC2026-02A200221-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200221-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200221-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200221-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200221-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200221-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200221-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200221-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200221-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200221-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200221-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200221-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200221-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312076Internal RxNorm lookup
314155Internal RxNorm lookup
351107Internal RxNorm lookup
351108Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
028aa88e-fa50-7aa8-cc0b-97c0c9a0357cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-307-12Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1017
59746-307-32Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING317

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-307-12EA - Each59746-3074a4a9741-66e9-4ea6-89a8-c825d7ac44bf12013-03-03
59746-307-32EA - Each59746-307ba081004-e5cf-4e22-b42b-1e2d116f902812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OlanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
OlanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
AspartameINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Hydroxypropyl Cellulose, Low SubstitutedINACTIVE INGREDIENT2165RE0K14OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Magnesium StearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
MannitolINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMOLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-307OLANZAPINE TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20250424_028aa88e-fa50-7aa8-cc0b-97c0c9a0357c.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEJubilant Cadista Pharmacuticals Inc.028aa88e-fa50-7aa8-cc0b-97c0c9a0357c2025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200221
application number: ANDA200221
ndc (product): 59746-307

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351107OLANZapine 15 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351108OLANZapine 20 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
314155OLANZapine 5 MG Disintegrating Oral TabletPSN028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
312076olanzapine 10 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351107olanzapine 15 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
351108olanzapine 20 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17
314155olanzapine 5 MG Disintegrating Oral TabletSCD028aa88e-fa50-7aa8-cc0b-97c0c9a0357c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-307-125974603071210 in 1 BLISTER PACKHistorical
59746-307-32597460307323 BLISTER PACK in 1 CARTON (59746-307-32) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59746-307-12) 3 blister pack2012-09-130000-00-00NoNoCurrent