Olanzapine

Product NDC
55111-265
11-digit product format
551110265
Labeler code
55111
Product ID
55111-265_ae2395b5-0918-65db-7001-41d52f121be7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA076534
Marketing category
ANDA
Marketing start
2011-10-24
Substance
OLANZAPINE
Active strength
20 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 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
A076534-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A076534-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A076534-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A076534-004OLANZAPINEOLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076534-001AB
A076534-002AB
A076534-003AB
A076534-004AB

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 UTC2026-02A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076534-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24d06236e962d9…

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 UTC2026-02A076534-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076534-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076534-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076534-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076534-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076534-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076534-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076534-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076534-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076534-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076534-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076534-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076534-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE20 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
aff02cff-d079-bc82-6182-a24c4c6e09a6Available 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
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-265-79Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1020
55111-265-81Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1020
55111-265-81Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-265-79EA - Each55111-265529da889-843e-4a08-aee7-7e7384b33ed712014-05-02
55111-265-81EA - Each55111-2658cda0261-8d46-4a46-aca7-0142ef80383d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
aspartameINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
CrospovidoneINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
magnesium stearateINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
mannitolINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]11
olanzapineACTIVE INGREDIENTN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
olanzapineACTIVE MOIETYN7U69T4SZROLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE TABLET, ORALLY DISINTEGRATING [TYA PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-265OLANZAPINE TABLET, ORALLY DISINTEGRATING [DR.REDDY'S LABORATORIES LIMITED]20Current NDC, Legacy NDC, 3 package rows20250429_aff02cff-d079-bc82-6182-a24c4c6e09a6.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
OlanzapineOLANZAPINEDr.Reddy's Laboratories Limitedaff02cff-d079-bc82-6182-a24c4c6e09a62026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076534
application number: ANDA076534
ndc (product): 55111-265

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
351107OLANZapine 15 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
351108OLANZapine 20 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
314155OLANZapine 5 MG Disintegrating Oral TabletPSNaff02cff-d079-bc82-6182-a24c4c6e09a620
312076olanzapine 10 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
351107olanzapine 15 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
351108olanzapine 20 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620
314155olanzapine 5 MG Disintegrating Oral TabletSCDaff02cff-d079-bc82-6182-a24c4c6e09a620

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-265-795511102657910 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-265-79) 2011-10-240000-00-00NoNoCurrent
55111-265-81551110265813 BLISTER PACK in 1 CARTON (55111-265-81) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2011-10-240000-00-00NoNoCurrent