Olanzapine

Product NDC
33342-084
11-digit product format
333420084
Labeler code
33342
Product ID
33342-084_54e61f27-1a30-4d62-8709-f7fe4023eb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203044
Marketing category
ANDA
Marketing start
2015-02-27
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A203044-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20
A203044-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20
A203044-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20
A203044-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203044-001AB
A203044-002AB
A203044-003AB
A203044-004AB

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 UTC2026-02A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203044-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2015-02-20d06236e962d9…

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 UTC2026-02A203044-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203044-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203044-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203044-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203044-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203044-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203044-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203044-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203044-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203044-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203044-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203044-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203044-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2027-12-31

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
df43938a-3469-40eb-8166-f0a2fd29d6d8Available 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
33342-084-07Olanzapine30 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING3012
33342-084-11Olanzapine100 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING10012
33342-084-12Olanzapine10 in 1 CARTONTABLET, ORALLY DISINTEGRATING1012
33342-084-12Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1012
33342-084-44Olanzapine1000 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-084-07EA - Each33342-084af06e3af-8890-4f19-94a2-b28733a60ef512015-09-10
33342-084-11EA - Each33342-0847df3ddc0-d48b-478b-9828-393747ee3cbd12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-084OLANZAPINE TABLET, ORALLY DISINTEGRATING [MACLEODS PHARMACEUTICALS LIMITED]11Current NDC, Legacy NDC, 5 package rows20250312_df43938a-3469-40eb-8166-f0a2fd29d6d8.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
OlanzapineOLANZAPINEMacleods Pharmaceuticals Limiteddf43938a-3469-40eb-8166-f0a2fd29d6d82026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203044
application number: ANDA203044
ndc (product): 33342-084

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
351107OLANZapine 15 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
351108OLANZapine 20 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
314155OLANZapine 5 MG Disintegrating Oral TabletPSNdf43938a-3469-40eb-8166-f0a2fd29d6d812
312076olanzapine 10 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
351107olanzapine 15 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
351108olanzapine 20 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812
314155olanzapine 5 MG Disintegrating Oral TabletSCDdf43938a-3469-40eb-8166-f0a2fd29d6d812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-084-073334200840730 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-07) 2015-02-270000-00-00NoNoCurrent
33342-084-1133342008411100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-11) 2015-02-270000-00-00NoNoCurrent
33342-084-123334200841210 BLISTER PACK in 1 CARTON (33342-084-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2015-02-270000-00-00NoNoCurrent
33342-084-44333420084441000 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-084-44) 2015-02-270000-00-00NoNoCurrent