Olanzapine

OLANZAPINE- olanzapine tablet, film coated
Zydus Lifesciences Limited

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1416-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 2.5 mg

Rx only

1,000 tablets

2.5 mg label
(click image for full-size original)

NDC 70771-1417-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 5 mg

Rx only

1,000 tablets

5 mg label
(click image for full-size original)

NDC 70771-1418-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 7.5 mg

Rx only

1,000 tablets

7.5 mg label
(click image for full-size original)

NDC 70771-1419-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 10 mg

Rx only

1,000 tablets

10 mg label
(click image for full-size original)

NDC 70771-1420-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 15 mg

Rx only

1,000 tablets

15 mg label
(click image for full-size original)

NDC 70771-1421-0 in bottle of 1,000 tablets

Olanzapine Tablets USP, 20 mg

Rx only

1,000 tablets

20 mg label
(click image for full-size original)
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1416
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZF28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1416-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1416-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1416-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1416-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1416-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1416-2)
5 NDC:70771-1416-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1416-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1417
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code ZF29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1417-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1417-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1417-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1417-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1417-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1417-2)
5 NDC:70771-1417-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1417-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1418
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code ZF30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1418-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1418-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1418-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1418-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1418-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1418-2)
5 NDC:70771-1418-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1418-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1419
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
CROSPOVIDONE
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code ZF31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1419-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1419-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1419-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1419-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1419-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1419-2)
5 NDC:70771-1419-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1419-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1420
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (ELLIPTICAL-SHAPED) Size 12mm
Flavor Imprint Code ZF32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1420-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1420-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1420-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1420-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1420-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1420-2)
5 NDC:70771-1420-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1420-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
OLANZAPINE
olanzapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1421
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape OVAL (ELLIPTICAL-SHAPED) Size 14mm
Flavor Imprint Code ZF33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1421-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1421-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70771-1421-1 100 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:70771-1421-0 1000 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:70771-1421-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1421-2)
5 NDC:70771-1421-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1421-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090459 01/03/2019
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1416), ANALYSIS (70771-1417), ANALYSIS (70771-1418), ANALYSIS (70771-1419), ANALYSIS (70771-1420), ANALYSIS (70771-1421), MANUFACTURE (70771-1416), MANUFACTURE (70771-1417), MANUFACTURE (70771-1418), MANUFACTURE (70771-1419), MANUFACTURE (70771-1420), MANUFACTURE (70771-1421)

Revised: 09/2023 Zydus Lifesciences Limited

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