sildenafil citrate by CarePartners Pharmacy, LLC

sildenafil citrate by

Drug Labeling and Warnings

sildenafil citrate by is a Prescription medication manufactured, distributed, or labeled by CarePartners Pharmacy, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TADALAFIL- tadalafil tablet, film coated 
SILDENAFIL- sildenafil tablet, film coated 
SILDENAFIL CITRATE- sildenafil tablet, film coated 
CarePartners Pharmacy, LLC

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Description of Sildenafil 5 mg and 100 mg Tablets

11. DESCRIPTION Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunction. Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:

Sildenafil citrate is a white or almost white, slightly hygroscopic crystalline powder. Slightly soluble in water & methanol, practically insoluble in hexane and a molecular weight of 666.7. Sildenafil tablets: Sildenafil tablets is white round, biconvex film coated tablets, debossed with R on one side and 20 on the other, containing sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate , each tablet contains the following inactive ingredients: Crospovidone, Hypromellose, Hydrophobic colloidal silica, Lactose monohydrate, Magnesium stearate, Microcrystalline cellulose, Titanium dioxide, and Triacetin.

Description of Tadalafil 5 mg and 20 mg Tablets

Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C H N O representing a molecular weight of 389.41. The structural formula is:


The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5yl)2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is freely soluble in dimethyl sulfoxide, slightly soluble in methylene chloride and practically insoluble in water Tadalafil Tablets USP are available as oval / almond shaped film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients : Lactose monohydrate, Microcrystalline Cellulose, Sodium Lauryl Sulphate, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Hypromellose, Titanium Dioxide, Triacetin, Talc and Yellow iron oxide. In addition, Tadalafil Tablets, 2.5 mg and 10 mg contains Red iron oxide

Sildenafil 20 mg and 100 mg oackage label.

Sildenafil 20 mg LabelSildenafil 100 mg Label

Tadalafil 5 mg and 20 mg Tablet Label

Tadalafil 5 mg TabletTadalafil 20 mg Tablet

TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73160-015(NDC: 29300-289)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL20 mg
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize12mm
FlavorImprint Code U;289
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73160-015-1212 in 1 BOTTLE; Type 0: Not a Combination Product03/26/201911/01/2019
2NDC: 73160-015-2525 in 1 BOTTLE; Type 0: Not a Combination Product03/26/201911/01/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925003/26/201911/01/2019
SILDENAFIL 
sildenafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73160-001(NDC: 42543-005)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL20 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code R;20
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73160-001-3030 in 1 BOTTLE; Type 0: Not a Combination Product08/01/201611/01/2019
2NDC: 73160-001-6060 in 1 BOTTLE; Type 0: Not a Combination Product08/01/201611/01/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20488308/01/201611/01/2019
TADALAFIL 
tadalafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73160-010(NDC: 29300-287)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TADALAFIL (UNII: 742SXX0ICT) (TADALAFIL - UNII:742SXX0ICT) TADALAFIL5 mg
Product Characteristics
ColoryellowScoreno score
ShapeOVALSize10mm
FlavorImprint Code U;287
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73160-010-3030 in 1 BOTTLE; Type 0: Not a Combination Product03/26/201911/01/2019
2NDC: 73160-010-6060 in 1 BOTTLE; Type 0: Not a Combination Product03/26/201911/01/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20925003/26/201911/01/2019
SILDENAFIL CITRATE 
sildenafil tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 73160-005(NDC: 60219-1753)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL100 mg
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize15mm
FlavorImprint Code AN355
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73160-005-1212 in 1 BOTTLE; Type 0: Not a Combination Product06/28/201811/01/2019
2NDC: 73160-005-2525 in 1 BOTTLE; Type 0: Not a Combination Product06/28/201811/01/2019
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20202306/28/201811/01/2019
Labeler - CarePartners Pharmacy, LLC (105568111)
Registrant - CarePartners Pharmacy, LLC (105568111)
Establishment
NameAddressID/FEIBusiness Operations
CarePartners Pharmacy, LLC105568111repack(73160-001, 73160-005, 73160-010, 73160-015) , relabel(73160-001, 73160-010, 73160-015) , label(73160-005)

Revised: 11/2019