Atorvastatin calcium tablet, film coated

Ingredients and appearance - Product information

Atorvastatin calcium tablet, film coated- Atorvastatin calcium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 42708-003
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Atorvastatin calcium trihydrate ( UNII: 48A5M73Z4Q)( Atorvastatin - UNII: A0JWA85V8F ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium carbonate ( UNII: H0G9379FGK)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hydroxypropyl cellulose (110000 wamw) ( UNII: 5Y0974F5PW)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (white to off-white) Size 10 mm
Shape OVAL Score 1
Imprint Code TV;5056

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205300 USA

Atorvastatin calcium tablet, film coated- Atorvastatin calcium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 42708-004
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Atorvastatin calcium trihydrate ( UNII: 48A5M73Z4Q)( Atorvastatin - UNII: A0JWA85V8F ) 20 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium carbonate ( UNII: H0G9379FGK)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hydroxypropyl cellulose (110000 wamw) ( UNII: 5Y0974F5PW)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (white to off-white) Size 12 mm
Shape OVAL Score 1
Imprint Code TV;5059

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205300 USA

Atorvastatin calcium tablet, film coated- Atorvastatin calcium

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 42708-005
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Atorvastatin calcium trihydrate ( UNII: 48A5M73Z4Q)( Atorvastatin - UNII: A0JWA85V8F ) 40 mgin 1

Inactive Ingredients

Ingredient Name Code
Calcium carbonate ( UNII: H0G9379FGK)
Croscarmellose sodium ( UNII: M28OL1HH48)
Hydroxypropyl cellulose (110000 wamw) ( UNII: 5Y0974F5PW)
Hypromellose 2910 (6 mpa.s) ( UNII: 0WZ8WG20P6)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color WHITE (white to off-white) Size 16 mm
Shape OVAL Score 1
Imprint Code TV;5058

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA205300 USA

Labeler - QPharma Inc( 030620888)

Establishment

Name ID/FEI Business Operations
QPharma Inc 030620888 REPACK( 42708-003, 42708-004, 42708-005)
Use with caution and with the lowest dose necessary (12.3)
Adverse Reaction 2% in any dose greater than placebo
Data given as x-fold change represent a simple ratio between coadministration and atorvastatin alone (i.e., 1 fold = no change). Data given as % change represent % difference relative to atorvastatin alone (i.e., 0% = no change).
See Sections 5.1 and 7 for clinical significance.
The dose of saquinavir plus ritonavir in this study is not the clinically used dose. The increase in atorvastatin exposure when used clinically is likely to be higher than what was observed in this study. Therefore, caution should be applied and the lowest dose necessary should be used.
Greater increases in AUC (up to 2.5 fold) and/or Cmax (up to 71%) have been reported with excessive grapefruit consumption ( 750 mL to 1.2 liters per day).
Single sample taken 8 to 16 h post dose.
Due to the dual interaction mechanism of rifampin, simultaneous coadministration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.
See Section 7 for clinical significance.
Atorvastatin 80 mg: atorvastatin 10 mg
Secondary endpoints not included in primary endpoint
Component of other secondary endpoints
Results are pooled from 2 dose-response studies.
A negative value for the 95% CI for the difference between treatments favors atorvastatin calcium for all except HDL-C, for which a positive value favors atorvastatin calcium. If the range does not include 0, this indicates a statistically significant difference.
Significantly different from lovastatin, ANCOVA, p 0.05
Significantly different from pravastatin, ANCOVA, p 0.05
Significantly different from simvastatin, ANCOVA, p 0.05