Lamivudine (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

NDC 64380-710-03

Lamivudine Tablets USP

150 mg

Rx only

60 Tablets

Each tablet contains 150 mg of lamivudine.

See prescribing information for dosage information.

Store lamivudine tablets at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature]. Protect from light.

Manufactured by:

Strides Shasun Limited

Bengaluru-562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revision: 07/2018

150mg 60ct Bottle
(click image for full-size original)

NDC 64380-711-04

Lamivudine Tablets USP

300 mg

R only

30 Tablets

Each tablet contains 150 mg of lamivudine.

See prescribing information for dosage information.

Store lamivudine tablets at 20° to 25°C (68° to 77°F)

[see USP Controlled Room Temperature]. Protect from light.

Manufactured by:

Strides Shasun Limited

Bengaluru-562106, India

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revision: 07/2018

300mg 30ct Bottle
(click image for full-size original)
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-710
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 150 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
POVIDONE K30
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape ROUND (circular biconvex) Size 9mm
Flavor Imprint Code TMT
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-710-03 60 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090457 04/19/2018
LAMIVUDINE lamivudine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE (LAMIVUDINE) LAMIVUDINE 300 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
POVIDONE K30
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
HYPROMELLOSE 2910 (5 MPA.S)
Product Characteristics
Color WHITE Score no score
Shape ROUND (circular biconvex) Size 12mm
Flavor Imprint Code L300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-711-04 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090457 04/19/2018
Labeler — Strides Shasun Limited (650738743)
Registrant — Strides Shasun Limited (650738743)
Establishment
Name Address ID/FEI Operations
Strides Shasun Limited 918513263 ANALYSIS (64380-710), ANALYSIS (64380-711), MANUFACTURE (64380-710), MANUFACTURE (64380-711), PACK (64380-710), PACK (64380-711)

Revised: 07/2018 Strides Shasun Limited

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