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 -- 40 mg Tablet Bottle Label
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 80 mg Tablet Bottle Label
(click image for full-size original)

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.