Products11
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zyprexa
Product Details
NDC Product Code
61269-633Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Zyprexa
Product Details
NDC Product Code
61269-630Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 2.5 mg in 1 1
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
ZYPREXA Intramuscular
Product Details
NDC Product Code
61269-640Application Number
NDA021253Marketing Category
NDA (C73594)Route of Administration
INTRAMUSCULAREffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 2 mL
Lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACTQuantity: 50 mg in 2 mL
Tartaric acidInactive
Code: W4888I119HClass: IACTQuantity: 3.5 mg in 2 mL
Hydrochloric acidInactive
Code: QTT17582CBClass: IACT
Sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
ZYPREXA Zydis
Product Details
NDC Product Code
61269-650Application Number
NDA021086Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
Methylparaben SodiumInactive
Code: CR6K9C2NHKClass: IACT
MannitolInactive
Code: 3OWL53L36AClass: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9NClass: IACT
AspartameInactive
Code: Z0H242BBR1Class: IACT
Zyprexa
Product Details
NDC Product Code
61269-634Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 15 mg in 1 1
Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
TriacetinInactive
Code: XHX3C3X673Class: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
FD&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584Class: IACT
Zyprexa
Product Details
NDC Product Code
61269-631Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 5 mg in 1 1
Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
Zyprexa
Product Details
NDC Product Code
61269-632Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 7.5 mg in 1 1
Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1AClass: IACT
Zyprexa
Product Details
NDC Product Code
61269-635Application Number
NDA020592Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
Crospovidone, UnspecifiedInactive
Code: 2S7830E561Class: IACT
Carnauba waxInactive
Code: R12CBM0EIZClass: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OHClass: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98GClass: IACT
Magnesium stearateInactive
Code: 70097M6I30Class: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WOClass: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
Titanium dioxideInactive
Code: 15FIX9V2JPClass: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675Class: IACT
Polyethylene glycol 4000Inactive
Code: 4R4HFI6D95Class: IACT
ZYPREXA Zydis
Product Details
NDC Product Code
61269-651Application Number
NDA021086Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 10 mg in 1 1
AspartameInactive
Code: Z0H242BBR1Class: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9NClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
Methylparaben SodiumInactive
Code: CR6K9C2NHKClass: IACT
MannitolInactive
Code: 3OWL53L36AClass: IACT
ZYPREXA Zydis
Product Details
NDC Product Code
61269-653Application Number
NDA021086Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 9, 2023Methylparaben SodiumInactive
Code: CR6K9C2NHKClass: IACT
OlanzapineActive
Code: N7U69T4SZRClass: ACTIBQuantity: 20 mg in 1 1
MannitolInactive
Code: 3OWL53L36AClass: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327LClass: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9NClass: IACT
AspartameInactive
Code: Z0H242BBR1Class: IACT
Showing 1 to 10 of 11 products