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Drug Product Composition: Naloxone Hydrochloride Dihydrate

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$ API Ref.Price (USD/KG) : 10,350Xls

USFDA APPLICATION NUMBER - 205637 / DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUPRENORPHINE HYDROCHLORIDE(UNII: 56W8MW3EN1)
(BUPRENORPHINE - UNII:40D3SCR4GZ)
BUPRENORPHINE6.3mg | 4.2mg | 2.1mg
naloxone hydrochloride dihydrate(UNII: 5Q187997EE)
(NALOXONE - UNII:36B82AMQ7N)
NALOXONE1mg | 0.7mg | 0.3mg

Inactive Ingredients

Ingredient Name
BioDelivery Sciences International, Inc.
.ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0)
ANHYDROUS CITRIC ACID(XF417D3PSL)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 38 MPA.S AT 2%)(YGX74DKE74)
DIBASIC POTASSIUM PHOSPHATE(CI71S98N1Z)
Ferric Oxide Yellow(EX438O2MRT)
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)(8136Y38GY5)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
Methylparaben(A2I8C7HI9T)
Polycarbophil(W25LM17A4W)
Propylene Glycol(6DC9Q167V3)
Propylparaben(Z8IX2SC1OH)
Saccharin Sodium(SB8ZUX40TY)
Sodium Benzoate(OJ245FE5EU)
Sodium Hydroxide(55X04QC32I)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU)