FDA.reportPublic FDA data

ZYPREXA

Product NDC
61269-660
11-digit product format
612690660
Labeler code
61269
Product ID
61269-660_9c56e9db-742e-4263-96b4-d92064f9baba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine pamoate
Dosage form
KIT
Route
INTRAMUSCULAR
Labeler
H2-Pharma LLC
Application
NDA022173
Marketing category
NDA
Marketing start
2009-12-11
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
Relprevv
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1718925, 1718928, 1718930, 1718932, 1718934, 1718936

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
61269-660-20ZYPREXARelprevv1 in 1 CARTONKIT168

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-660-20EA - Each61269-660e298adfd-3a4c-4947-81e9-d76fe914483c12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-660ZYPREXA RELPREVV (OLANZAPINE PAMOATE) KIT [H2-PHARMA LLC]64Current NDC, 1 package rows20250207_11544cba-64a9-49cb-8d74-da228053b252.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1718934OLANZapine 210 MG Extended Release InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718930OLANZapine 300 MG Extended Release InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718925OLANZapine 405 MG Extended Release InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718936ZyPREXA Relprevv 210 MG InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718932ZyPREXA Relprevv 300 MG InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718928ZyPREXA Relprevv 405 MG InjectionPSN11544cba-64a9-49cb-8d74-da228053b25268
1718936olanzapine 210 MG Injection [Zyprexa]SBD11544cba-64a9-49cb-8d74-da228053b25268
1718932olanzapine 300 MG Injection [Zyprexa]SBD11544cba-64a9-49cb-8d74-da228053b25268
1718928olanzapine 405 MG Injection [Zyprexa]SBD11544cba-64a9-49cb-8d74-da228053b25268
1718934olanzapine 210 MG InjectionSCD11544cba-64a9-49cb-8d74-da228053b25268
1718930olanzapine 300 MG InjectionSCD11544cba-64a9-49cb-8d74-da228053b25268
1718925olanzapine 405 MG InjectionSCD11544cba-64a9-49cb-8d74-da228053b25268
1718934olanzapine 210 MG (as olanzapine pamoate monohydrate 483 MG) InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718930olanzapine 300 MG (as olanzapine pamoate monohydrate 690 MG) InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718925olanzapine 405 MG (as olanzapine pamoate monohydrate 931 MG) InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718936Zyprexa 210 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718932Zyprexa 300 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718928Zyprexa 405 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718936Zyprexa Relprevv 210 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718932Zyprexa Relprevv 300 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268
1718928Zyprexa Relprevv 405 MG InjectionSY11544cba-64a9-49cb-8d74-da228053b25268

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61269-660-20612690660201 KIT in 1 CARTON (61269-660-20) * 1.4 mL in 1 VIAL * 3 mL in 1 VIAL1 kit2010-03-01NoNoCurrent