Atorvastatin Calcium (Page 11 of 11)

Principal Display Panel

NDC: 51655-464-52

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:51655-464(NDC:67877-512)
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
MICROCRYSTALLINE CELLULOSE 101
CALCIUM CARBONATE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (110000 WAMW)
POLYSORBATE 80
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 6000
TITANIUM DIOXIDE
TALC
Product Characteristics
Color white Score no score
Shape OVAL (elliptical) Size 12mm
Flavor Imprint Code 20;ATS
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-464-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209288 10/27/2020
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-464)

Revised: 08/2021 Northwind Pharmaceuticals, LLC

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