FDA.reportPublic FDA data

ZYPREXA

Product NDC
61269-640
11-digit product format
612690640
Labeler code
61269
Product ID
61269-640_40d4ed67-c51d-40d0-8a32-ecfdbf069f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
H2-Pharma LLC
Application
NDA021253
Marketing category
NDA
Marketing start
2004-04-01
Substance
OLANZAPINE
Active strength
10 mg/2mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYPREXA
Brand name suffix
Intramuscular
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE10 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui153046, 153047, 153048, 200034, 212405, 261337, 283639, 284514, 312076, 312077, 312078, 312079, 314154, 314155, 351107, 351108, 485968, 545353, 754503, 754504

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
61269-640-20ZYPREXA Intramuscular1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION168
61269-640-20ZYPREXA Intramuscular2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION268

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-640-20EA - Each61269-64035650d19-df62-40a6-99fd-3b10651a83cf12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-640ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [H2-PHARMA LLC]66Current NDC, 2 package rows20250207_b418946a-1ab4-4d89-a012-d94fc361a3c4.zip

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
61269-640-20612690640201 VIAL in 1 CARTON (61269-640-20) / 2 mL in 1 VIAL1 vial2004-04-01NoNoHistorical