FDA.reportPublic FDA data

ZYPREXA

Product NDC
0002-7597
11-digit product format
000027597
Labeler code
0002
Product ID
0002-7597_9073f34c-307c-4a3a-8273-580ef5742229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Eli Lilly and Company
Application
NDA021253
Marketing category
NDA
Marketing start
2004-04-01
Marketing end
2026-06-30
Substance
OLANZAPINE
Active strength
10 mg/2mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYPREXA
Brand name suffix
Intramuscular

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
0002-7597-01ZYPREXA Intramuscular1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION167
0002-7597-01ZYPREXA Intramuscular2 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION267

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0002-7597-01EA - Each0002-7597659a6fb4-1a17-4371-9476-3366a8ecca7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OlanzapineACTIVE INGREDIENTN7U69T4SZRZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
OlanzapineACTIVE MOIETYN7U69T4SZRZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
AspartameINACTIVE INGREDIENTZ0H242BBR1ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Carnauba waxINACTIVE INGREDIENTR12CBM0EIZZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
CrospovidoneINACTIVE INGREDIENT68401960MKZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
GelatinINACTIVE INGREDIENT2G86QN327LZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
LactoseINACTIVE INGREDIENTJ2B2A4N98GZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Magnesium stearateINACTIVE INGREDIENT70097M6I30ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
MannitolINACTIVE INGREDIENT3OWL53L36AZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Methylparaben SodiumINACTIVE INGREDIENTCR6K9C2NHKZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Polyethylene glycol 4000INACTIVE INGREDIENT4R4HFI6D95ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Propylparaben SodiumINACTIVE INGREDIENT625NNB0G9NZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Tartaric acidINACTIVE INGREDIENTW4888I119HZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
Titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45
TriacetinINACTIVE INGREDIENTXHX3C3X673ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-7597ZYPREXA (OLANZAPINE) TABLET ZYPREXA ZYDIS (OLANZAPINE) TABLET, ORALLY DISINTEGRATING ZYPREXA INTRAMUSCULAR (OLANZAPINE) INJECTION, POWDER, FOR SOLUTION [ELI LILLY AND COMPANY ]66Current NDC, Legacy NDC, 2 package rows20250110_d5051fbc-846b-4946-82df-341fb1216341.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312076OLANZapine 10 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
485968OLANZapine 10 MG InjectionPSNd5051fbc-846b-4946-82df-341fb121634167
314154OLANZapine 10 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
351107OLANZapine 15 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
312077OLANZapine 15 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
200034OLANZapine 2.5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
351108OLANZapine 20 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
283639OLANZapine 20 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
314155OLANZapine 5 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
312078OLANZapine 5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
312079OLANZapine 7.5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
545353ZyPREXA 10 MG InjectionPSNd5051fbc-846b-4946-82df-341fb121634167
153048ZyPREXA 10 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
261337ZyPREXA 15 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
212405ZyPREXA 2.5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
284514ZyPREXA 20 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
153046ZyPREXA 5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
153047ZyPREXA 7.5 MG Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
754503ZyPREXA ZYDIS 10 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
754504ZyPREXA ZYDIS 15 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
754505ZyPREXA ZYDIS 20 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
754506ZyPREXA ZYDIS 5 MG Disintegrating Oral TabletPSNd5051fbc-846b-4946-82df-341fb121634167
754503olanzapine 10 MG Disintegrating Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
545353olanzapine 10 MG Injection [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
153048olanzapine 10 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
754504olanzapine 15 MG Disintegrating Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
261337olanzapine 15 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
212405olanzapine 2.5 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
754505olanzapine 20 MG Disintegrating Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
284514olanzapine 20 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
754506olanzapine 5 MG Disintegrating Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
153046olanzapine 5 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
153047olanzapine 7.5 MG Oral Tablet [Zyprexa]SBDd5051fbc-846b-4946-82df-341fb121634167
312076olanzapine 10 MG Disintegrating Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
485968olanzapine 10 MG InjectionSCDd5051fbc-846b-4946-82df-341fb121634167
314154olanzapine 10 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
351107olanzapine 15 MG Disintegrating Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
312077olanzapine 15 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
200034olanzapine 2.5 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
351108olanzapine 20 MG Disintegrating Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
283639olanzapine 20 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
314155olanzapine 5 MG Disintegrating Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
312078olanzapine 5 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
312079olanzapine 7.5 MG Oral TabletSCDd5051fbc-846b-4946-82df-341fb121634167
545353Zyprexa 10 MG InjectionSYd5051fbc-846b-4946-82df-341fb121634167
153048Zyprexa 10 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
261337Zyprexa 15 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
212405Zyprexa 2.5 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
284514Zyprexa 20 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
754506Zyprexa 5 MG Disintegrating Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
153046Zyprexa 5 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
153047Zyprexa 7.5 MG Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
754503Zyprexa Zydis 10 MG Disintegrating Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
754504Zyprexa Zydis 15 MG Disintegrating Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
754505Zyprexa Zydis 20 MG Disintegrating Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
754506Zyprexa Zydis 5 MG Disintegrating Oral TabletSYd5051fbc-846b-4946-82df-341fb121634167
485968OLANZapine 10 MG InjectionPSN85688d8f-f2de-408a-8ae2-0976c266c9612
545353ZyPREXA 10 MG InjectionPSN85688d8f-f2de-408a-8ae2-0976c266c9612
545353olanzapine 10 MG Injection [Zyprexa]SBD85688d8f-f2de-408a-8ae2-0976c266c9612
485968olanzapine 10 MG InjectionSCD85688d8f-f2de-408a-8ae2-0976c266c9612
545353Zyprexa 10 MG InjectionSY85688d8f-f2de-408a-8ae2-0976c266c9612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0002-7597-01000027597011 VIAL in 1 CARTON (0002-7597-01) / 2 mL in 1 VIAL1 vial2004-04-012026-06-30NoNoCurrent