Zyprexa

Product NDC
61269-632
11-digit product format
612690632
Labeler code
61269
Product ID
61269-632_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
H2-Pharma LLC
Application
NDA020592
Marketing category
NDA
Marketing start
1996-10-01
Substance
OLANZAPINE
Active strength
7.5 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020592-001ZYPREXAOLANZAPINE2.5MGTABLET / ORALABRLD1996-09-30
N020592-002ZYPREXAOLANZAPINE5MGTABLET / ORALABRLD, RS1996-09-30
N020592-003ZYPREXAOLANZAPINE7.5MGTABLET / ORALABRLD1996-09-30
N020592-004ZYPREXAOLANZAPINE10MGTABLET / ORALABRLD1996-09-30
N020592-005ZYPREXAOLANZAPINE15MGTABLET / ORALABRLD1997-09-09
N020592-006ZYPREXAOLANZAPINE20MGTABLET / ORALABRLD1997-09-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020592-001AB
N020592-002AB
N020592-003AB
N020592-004AB
N020592-005AB
N020592-006AB

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-005ZYPREXA15MGTABLET / ORALABRLD1997-09-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-006ZYPREXA20MGTABLET / ORALABRLD1997-09-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-001ZYPREXA2.5MGTABLET / ORALABRLD1996-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-002ZYPREXA5MGTABLET / ORALABRLD, RS1996-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-003ZYPREXA7.5MGTABLET / ORALABRLD1996-09-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-004ZYPREXA10MGTABLET / ORALABRLD1996-09-302680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020592-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020592-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020592-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020592-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020592-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020592-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020592-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020592-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020592-004AB12680178bc6a6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE7.5 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 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
153046Internal RxNorm lookup
153047Internal RxNorm lookup
153048Internal RxNorm lookup
200034Internal RxNorm lookup
212405Internal RxNorm lookup
261337Internal RxNorm lookup
283639Internal RxNorm lookup
284514Internal RxNorm lookup
312076Internal RxNorm lookup
312077Internal RxNorm lookup
312078Internal RxNorm lookup
312079Internal RxNorm lookup
314154Internal RxNorm lookup
314155Internal RxNorm lookup
351107Internal RxNorm lookup
351108Internal RxNorm lookup
485968Internal RxNorm lookup
545353Internal RxNorm lookup
754503Internal RxNorm lookup
754504Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b418946a-1ab4-4d89-a012-d94fc361a3c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-632-30Zyprexa30 in 1 BOTTLETABLET3068

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-632ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [H2-PHARMA LLC]66Current NDC, 1 package rows20250207_b418946a-1ab4-4d89-a012-d94fc361a3c4.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
ZyprexaOLANZAPINEH2-Pharma LLCb418946a-1ab4-4d89-a012-d94fc361a3c42026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020592
application number: NDA020592
ndc (product): 61269-632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
485968OLANZapine 10 MG InjectionPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
314154OLANZapine 10 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
351107OLANZapine 15 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
312077OLANZapine 15 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
200034OLANZapine 2.5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
351108OLANZapine 20 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
283639OLANZapine 20 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
314155OLANZapine 5 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
312078OLANZapine 5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
312079OLANZapine 7.5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
545353ZyPREXA 10 MG InjectionPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
153048ZyPREXA 10 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
261337ZyPREXA 15 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
212405ZyPREXA 2.5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
284514ZyPREXA 20 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
153046ZyPREXA 5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
153047ZyPREXA 7.5 MG Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
754503ZyPREXA ZYDIS 10 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
754504ZyPREXA ZYDIS 15 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
754505ZyPREXA ZYDIS 20 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
754506ZyPREXA ZYDIS 5 MG Disintegrating Oral TabletPSNb418946a-1ab4-4d89-a012-d94fc361a3c468
754503olanzapine 10 MG Disintegrating Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
545353olanzapine 10 MG Injection [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
153048olanzapine 10 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
754504olanzapine 15 MG Disintegrating Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
261337olanzapine 15 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
212405olanzapine 2.5 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
754505olanzapine 20 MG Disintegrating Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
284514olanzapine 20 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
754506olanzapine 5 MG Disintegrating Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
153046olanzapine 5 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
153047olanzapine 7.5 MG Oral Tablet [Zyprexa]SBDb418946a-1ab4-4d89-a012-d94fc361a3c468
312076olanzapine 10 MG Disintegrating Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
485968olanzapine 10 MG InjectionSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
314154olanzapine 10 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
351107olanzapine 15 MG Disintegrating Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
312077olanzapine 15 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
200034olanzapine 2.5 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
351108olanzapine 20 MG Disintegrating Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
283639olanzapine 20 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
314155olanzapine 5 MG Disintegrating Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
312078olanzapine 5 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
312079olanzapine 7.5 MG Oral TabletSCDb418946a-1ab4-4d89-a012-d94fc361a3c468
545353Zyprexa 10 MG InjectionSYb418946a-1ab4-4d89-a012-d94fc361a3c468
153048Zyprexa 10 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
261337Zyprexa 15 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
212405Zyprexa 2.5 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
284514Zyprexa 20 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
754506Zyprexa 5 MG Disintegrating Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
153046Zyprexa 5 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
153047Zyprexa 7.5 MG Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
754503Zyprexa Zydis 10 MG Disintegrating Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
754504Zyprexa Zydis 15 MG Disintegrating Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
754505Zyprexa Zydis 20 MG Disintegrating Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468
754506Zyprexa Zydis 5 MG Disintegrating Oral TabletSYb418946a-1ab4-4d89-a012-d94fc361a3c468

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61269-632-306126906323030 TABLET in 1 BOTTLE (61269-632-30) 30 tablet1996-10-01NoNoCurrent