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Drug Product Composition: Clarithromycin

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$ API Ref.Price (USD/KG) : 213Xls

USFDA APPLICATION NUMBER - 50775 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLARITHROMYCIN(UNII: H1250JIK0A)
(CLARITHROMYCIN - UNII:H1250JIK0A)
CLARITHROMYCIN500mg | 500mg

Inactive Ingredients

Ingredient Name
Zydus Pharmaceuticals USA Inc
AbbVie Inc.
A-S Medication Solutions LLC
CARBOMER 1342(809Y72KV36)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(809Y72KV36)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(HHT01ZNK31)  
CASTOR OIL(D5340Y2I9G) 
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) 
CITRIC ACID MONOHYDRATE(2968PHW8QP)  
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD) 
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) 
HYDROXYPROPYL CELLULOSE(RFW2ET671P)  
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)  
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(G4U024CQK6) 
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D) 
POTASSIUM SORBATE(1VPU26JZZ4) 
POVIDONE(FZ989GH94E) 
POVIDONES(FZ989GH94E)  
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SORBIC ACID(X045WJ989B)
SORBITAN MONOOLEATE(06XEA2VD56)
STARCH, CORN(O8232NY3SJ)  
STEARIC ACID(4ELV7Z65AP) 
SUCROSE(C151H8M554) 
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
VANILLIN(CHI530446X)
XANTHAN GUM(TTV12P4NEE)