FDA.reportPublic FDA data

Olanzapine Orally Disintegrating Tablets

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-12-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:42:12

Label at a glance#

ProductOlanzapine
Active ingredientOLANZAPINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1814-0

Olanzapine Orally Disintegrating Tablets USP, 5 mg

Rx only

1,000 tablets

5 mg label
5 mg label

NDC 70771-1815-0

Olanzapine Orally Disintegrating Tablets USP, 10 mg

Rx only

1,000 tablets

10 mg label
10 mg label

NDC 70771-1816-0

Olanzapine Orally Disintegrating Tablets USP, 15 mg

Rx only

1,000 tablets

15 mg label
15 mg label

NDC 70771-1817-0

Olanzapine Orally Disintegrating Tablets USP, 20 mg

Rx only

1,000 tablets

20 mg label
20 mg label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-181470771-1814-3, 70771-1814-9, 70771-1814-1, 70771-1814-5, 70771-1814-0
70771-181570771-1815-3, 70771-1815-9, 70771-1815-1, 70771-1815-5, 70771-1815-0
70771-181670771-1816-3, 70771-1816-9, 70771-1816-1, 70771-1816-5, 70771-1816-0
70771-181770771-1817-3, 70771-1817-9, 70771-1817-1, 70771-1817-5, 70771-1817-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLANZAPINEN7U69T4SZRACTIB
ASPARTAMEZ0H242BBR1IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
MANNITOL3OWL53L36AIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
ORANGE5EVU04N5QUIACT
CROSPOVIDONE2S7830E561IACT
OLANZAPINEN7U69T4SZRACTIB
ASPARTAMEZ0H242BBR1IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSPOVIDONE2S7830E561IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
ORANGE5EVU04N5QUIACT
OLANZAPINEN7U69T4SZRACTIB
ASPARTAMEZ0H242BBR1IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSPOVIDONE2S7830E561IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
ORANGE5EVU04N5QUIACT
OLANZAPINEN7U69T4SZRACTIB
ASPARTAMEZ0H242BBR1IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
CROSPOVIDONE2S7830E561IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER905HNO1SIHIACT
MAGNESIUM STEARATE70097M6I30IACT
MANNITOL3OWL53L36AIACT
ORANGE5EVU04N5QUIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e00d973a-837f-4a7b-ab1c-d19b566d55aede211e8c-721b-4f8d-99cf-4607803e6b4e2025-04-29Exact identifier
spl set id: de211e8c-721b-4f8d-99cf-4607803e6b4e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.