Atorvastatin Calcium (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL — 40 mg Tablet Bottle Label

NDC 82137-018-01

Atorvastatin Calcium

Tablets

40 mg*

90 Tablets Rx only

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL — 80 mg Tablet Bottle Label

NDC 82137-019-01

Atorvastatin Calcium

Tablets

80 mg*

90 Tablets Rx only

ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82137-016 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 10 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (90000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TALC TITANIUM DIOXIDE POLYSORBATE 80

Product Characteristics Color white (white or off white) Score no score Shape OVAL (elliptical) Size 5mm Flavor Imprint Code l Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82137-016-01 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216848 11/01/2022

ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82137-017 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 20 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (90000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TALC TITANIUM DIOXIDE POLYSORBATE 80

Product Characteristics Color white (white or off white) Score no score Shape OVAL (elliptical) Size 6mm Flavor Imprint Code ll Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82137-017-01 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216848 11/01/2022

ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82137-018 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 40 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (90000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TALC TITANIUM DIOXIDE POLYSORBATE 80

Product Characteristics Color white (white or off white) Score no score Shape OVAL (elliptical) Size 8mm Flavor Imprint Code lll Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82137-018-01 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216848 11/01/2022

ATORVASTATIN CALCIUM atorvastatin calcium tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:82137-019 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATORVASTATIN CALCIUM TRIHYDRATE (ATORVASTATIN) ATORVASTATIN 80 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE CROSCARMELLOSE SODIUM HYDROXYPROPYL CELLULOSE (90000 WAMW) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TALC TITANIUM DIOXIDE POLYSORBATE 80

Product Characteristics Color white (white or off white) Score no score Shape OVAL (elliptical) Size 10mm Flavor Imprint Code llll Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:82137-019-01 90 TABLET, FILM COATED in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA216848 11/01/2022

Labeler — Lepu Pharmaceutical Technology Co., Ltd. (544490278)

Registrant — Lepu Pharmaceutical Technology Co., Ltd. (544490278)

Establishment
Name	Address	ID/FEI	Operations
Lepu Pharmaceutical Technology Co., Ltd.		544490278	analysis (82137-016), manufacture (82137-016), manufacture (82137-017), manufacture (82137-018), manufacture (82137-019), pack (82137-016), pack (82137-017), pack (82137-018), pack (82137-019), label (82137-016), label (82137-017), label (82137-018), label (82137-019), analysis (82137-017), analysis (82137-018), analysis (82137-019)

Revised: 11/2022 Lepu Pharmaceutical Technology Co., Ltd.