Zyprexa
These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial U.S. Approval: 1996
Approved
Approval ID
b418946a-1ab4-4d89-a012-d94fc361a3c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
H2-Pharma LLC
DUNS: 028473634
Products 10
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-633
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
OlanzapineActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-630
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
OlanzapineActive
Quantity: 2.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-640
Application NumberNDA021253
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (5)
OlanzapineActive
Quantity: 10 mg in 2 mL
Code: N7U69T4SZR
Classification: ACTIB
Lactose monohydrateInactive
Quantity: 50 mg in 2 mL
Code: EWQ57Q8I5X
Classification: IACT
Tartaric acidInactive
Quantity: 3.5 mg in 2 mL
Code: W4888I119H
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-650
Application NumberNDA021086
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (6)
OlanzapineActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Methylparaben SodiumInactive
Code: CR6K9C2NHK
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9N
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-634
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 15 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-631
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-632
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 7.5 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Polyethylene Glycol, UnspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-635
Application NumberNDA020592
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (11)
OlanzapineActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
Hydroxypropyl Cellulose, UnspecifiedInactive
Code: 9XZ8H6N6OH
Classification: IACT
Lactose, Unspecified FormInactive
Code: J2B2A4N98G
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Polyethylene glycol 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-651
Application NumberNDA021086
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (6)
OlanzapineActive
Quantity: 10 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
AspartameInactive
Code: Z0H242BBR1
Classification: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9N
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Methylparaben SodiumInactive
Code: CR6K9C2NHK
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Olanzapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61269-653
Application NumberNDA021086
Product Classification
M
Marketing Category
C73594
G
Generic Name
Olanzapine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (6)
Methylparaben SodiumInactive
Code: CR6K9C2NHK
Classification: IACT
OlanzapineActive
Quantity: 20 mg in 1 1
Code: N7U69T4SZR
Classification: ACTIB
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Propylparaben SodiumInactive
Code: 625NNB0G9N
Classification: IACT
AspartameInactive
Code: Z0H242BBR1
Classification: IACT