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Drug Product Composition: Naltrexone Hydrochloride

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$ API Ref.Price (USD/KG) : 6,899Xls

USFDA APPLICATION NUMBER - 22321 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
MORPHINE SULFATE(UNII: X3P646A2J0)
(MORPHINE - UNII:76I7G6D29C)
MORPHINE SULFATE100mg | 80mg | 60mg | 50mg | 30mg | 20mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM)
NALTREXONE HYDROCHLORIDE4mg | 3.2mg | 2.4mg | 2mg | 1.2mg | 0.8mg

Inactive Ingredients

Ingredient Name
Pfizer Laboratories Div Pfizer Inc
AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2)
ASCORBIC ACID(PQ6CK8PD0R)
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
DIBUTYL SEBACATE(4W5IH7FLNY)
DIETHYL PHTHALATE(UF064M00AF)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
MAGNESIUM STEARATE(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)