NDC Code(s) : 69097-166-03, 69097-167-02
Packager : Cipla USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LAMIVUDINELAMIVUDINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE(UNII: 2T8Q726O95)
(LAMIVUDINE - UNII:2T8Q726O95) 		LAMIVUDINE150 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score 2 pieces
Shape CAPSULE Size 12 mm
Flavor Imprint Code C1;66
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-166-0360 in 1 BOTTLE Type 0: Not a Combination Product03/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077221 03/03/2017
LAMIVUDINELAMIVUDINE TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69097-167
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LAMIVUDINE(UNII: 2T8Q726O95)
(LAMIVUDINE - UNII:2T8Q726O95) 		LAMIVUDINE300 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE B POTATO(UNII: 27NA468985)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17 mm
Flavor Imprint Code C167
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69097-167-0230 in 1 BOTTLE Type 0: Not a Combination Product03/03/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077221 03/03/2017

LABELER - Cipla USA Inc.(078719707)

REGISTRANT - Cipla USA Inc.(078719707)

Establishment
Name Address ID/FEI Business Operations
Cipla Kurkumbh 917066446 API MANUFACTURE(69097-166, 69097-167)

Establishment
Name Address ID/FEI Business Operations
Cipla Ltd.- Goa 650072015 MANUFACTURE(69097-166, 69097-167)

PRINCIPAL DISPLAY PANEL

NDC 69097-167-02   Rx ONLY

Lamivudine Tablets, USP

300 mg

30 Tablets

Cipla

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NDC 69097-166-03   Rx ONLY

Lamivudine Tablets, USP

150 mg

60 Tablets

Cipla

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