FDA.reportPublic FDA data

Olanzapine

Product NDC
64380-174
11-digit product format
643800174
Labeler code
64380
Product ID
64380-174_4b3cec46-acb7-4072-b226-d5c7c06b33b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA078109
Marketing category
ANDA
Marketing start
2022-04-11
Substance
OLANZAPINE
Active strength
15 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
A078109-001OLANZAPINEOLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-002OLANZAPINEOLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-003OLANZAPINEOLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24
A078109-004OLANZAPINEOLANZAPINE20MGTABLET, 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
A078109-001AB
A078109-002AB
A078109-003AB
A078109-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078109-001OLANZAPINE5MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24a50c72e98297…
2026-08-01 22:54:322026-06A078109-002OLANZAPINE10MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24a50c72e98297…
2026-08-01 22:54:322026-06A078109-003OLANZAPINE15MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24a50c72e98297…
2026-08-01 22:54:322026-06A078109-004OLANZAPINE20MGTABLET, ORALLY DISINTEGRATING / ORALAB2011-10-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078109-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078109-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078109-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078109-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OlanzapineOLANZAPINEStrides Pharma Science Limited979c3212-36e8-4287-aace-bef0875188d72026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078109
application number: ANDA078109
ndc (product): 64380-174

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE15 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
979c3212-36e8-4287-aace-bef0875188d7Available 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
64380-174-01Olanzapine10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING105
64380-174-02Olanzapine3 in 1 CARTONTABLET, ORALLY DISINTEGRATING35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-174-01EA - Each64380-174bcded1c1-bd91-4a15-a432-fc66974bcde312022-11-07
64380-174-02EA - Each64380-1747aa73184-4707-4bdd-97f2-042c51e3dd4012022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-174OLANZAPINE TABLET, ORALLY DISINTEGRATING [STRIDES PHARMA SCIENCE LIMITED]5Current NDC, Legacy NDC, 2 package rows20250226_979c3212-36e8-4287-aace-bef0875188d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSN979c3212-36e8-4287-aace-bef0875188d75
351107OLANZapine 15 MG Disintegrating Oral TabletPSN979c3212-36e8-4287-aace-bef0875188d75
351108OLANZapine 20 MG Disintegrating Oral TabletPSN979c3212-36e8-4287-aace-bef0875188d75
314155OLANZapine 5 MG Disintegrating Oral TabletPSN979c3212-36e8-4287-aace-bef0875188d75
312076olanzapine 10 MG Disintegrating Oral TabletSCD979c3212-36e8-4287-aace-bef0875188d75
351107olanzapine 15 MG Disintegrating Oral TabletSCD979c3212-36e8-4287-aace-bef0875188d75
351108olanzapine 20 MG Disintegrating Oral TabletSCD979c3212-36e8-4287-aace-bef0875188d75
314155olanzapine 5 MG Disintegrating Oral TabletSCD979c3212-36e8-4287-aace-bef0875188d75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-174-016438001740110 in 1 BLISTER PACKHistorical
64380-174-02643800174023 BLISTER PACK in 1 CARTON (64380-174-02) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (64380-174-01) 3 blister pack2022-04-110000-00-00NoNoCurrent