USFDA APPLICATION NUMBER - 21121 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 18MG
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49) | METHYLPHENIDATE HYDROCHLORIDE | 27mg | 18mg | 54mg | 36mg |
Inactive Ingredients
Ingredient Name | Alvogen Inc. | ANI Pharmaceuticals, Inc. | Impax Generics | Actavis Pharma, Inc. | American Health Packaging | Avera McKennan Hospital | Bryant Ranch Prepack | Camber Pharmaceuticals, Inc. | Dr.Reddys Laboratories Inc | Mylan Pharmaceuticals Inc. | Northstar Rx LLC | XLCare Pharmaceuticals, Inc. | AvKARE, Inc. |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
AMMONIA(5138Q19F1X) | |||||||||||||
Anhydrous Citric Acid(XF417D3PSL) | |||||||||||||
BUTYL ALCOHOL(8PJ61P6TS3) | |||||||||||||
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K) | |||||||||||||
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 400 MPA.S AT 1%)(FC40A8XAJ3) | |||||||||||||
CARBOXYMETHYLCELLULOSE SODIUM(K679OBS311) | |||||||||||||
CARNAUBA WAX(R12CBM0EIZ) | |||||||||||||
CELLULOSE ACETATE(3J2P07GVB6) | |||||||||||||
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U) | |||||||||||||
CETYL ALCOHOL(936JST6JCN) | |||||||||||||
D&C Red No. 27(2LRS185U6K) | |||||||||||||
D&C Yellow No. 10(35SW5USQ3G) | |||||||||||||
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62) | |||||||||||||
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | |||||||||||||
ETHYLCELLULOSES(7Z8S9VYZ4B) | |||||||||||||
FD&C BLUE NO. 1(H3R47K3TBD) | |||||||||||||
Fd&C Blue No. 2(L06K8R7DQK) | |||||||||||||
Fd&C Red No. 40(WZB9127XOA) | |||||||||||||
Fd&C Yellow No. 6(H77VEI93A8) | |||||||||||||
FERRIC OXIDE RED(1K09F3G675) | |||||||||||||
FERRIC OXIDE YELLOW(EX438O2MRT) | |||||||||||||
FERROSOFERRIC OXIDE (XM0M87F357) | |||||||||||||
FERROSOFERRIC OXIDE(XM0M87F357) | |||||||||||||
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P) | |||||||||||||
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH) | |||||||||||||
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI) | |||||||||||||
Hypromellose 2910 (3 Mpa.S)(0VUT3PMY82) | |||||||||||||
Hypromellose 2910 (6 Mpa.S)(0WZ8WG20P6) | |||||||||||||
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W) | |||||||||||||
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | |||||||||||||
HYPROMELLOSES(3NXW29V3WO) | |||||||||||||
ISOPROPYL ALCOHOL(ND2M416302) | |||||||||||||
LACTOSE MONOHYDRATE(EWQ57Q8I5X) | |||||||||||||
lactose(J2B2A4N98G) | |||||||||||||
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G) | |||||||||||||
LECITHIN, SOYBEAN(1DI56QDM62) | |||||||||||||
MAGNESIUM STEARATE(70097M6I30) | |||||||||||||
PHOSPHORIC ACID(E4GA8884NN) | |||||||||||||
POLOXAMER 124(1S66E28KXA) | |||||||||||||
Poloxamer 188(LQA7B6G8JG) | |||||||||||||
Polyethylene Glycol 2000000(5K3991GVWI) | |||||||||||||
POLYETHYLENE GLYCOL 3350(G2M7P15E5P) | |||||||||||||
Polyethylene Glycol 7000000(G3MS6M810Y) | |||||||||||||
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | |||||||||||||
POLYETHYLENE GLYCOLS(3WJQ0SDW1A) | |||||||||||||
POLYETHYLENE OXIDE 100000(V46Y6OJ5QB) | |||||||||||||
POLYETHYLENE OXIDE 200000(11628IH70O) | |||||||||||||
POLYETHYLENE OXIDE 7000000(G3MS6M810Y) | |||||||||||||
POLYSORBATE 80(6OZP39ZG8H) | |||||||||||||
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990) | |||||||||||||
Povidone K30(U725QWY32X) | |||||||||||||
POVIDONE(FZ989GH94E) | |||||||||||||
povidone, unspecified(FZ989GH94E) | |||||||||||||
povidones(FZ989GH94E) | |||||||||||||
PROPYLENE GLYCOL(6DC9Q167V3) | |||||||||||||
SHELLAC(46N107B71O) | |||||||||||||
SILICON DIOXIDE(ETJ7Z6XBU4) | |||||||||||||
SODIUM CHLORIDE(451W47IQ8X) | |||||||||||||
SODIUM LAURYL SULFATE(368GB5141J) | |||||||||||||
SODIUM STEARYL FUMARATE(7CV7WJK4UI) | |||||||||||||
STARCH, CORN(O8232NY3SJ) | |||||||||||||
STEARIC ACID(4ELV7Z65AP) | |||||||||||||
SUCCINIC ACID(AB6MNQ6J6L) | |||||||||||||
SUCROSE(C151H8M554) | |||||||||||||
TALC(7SEV7J4R1U) | |||||||||||||
titanium dioxide(15FIX9V2JP) | |||||||||||||
triacetin(XHX3C3X673) | |||||||||||||
TRIETHYL CITRATE(8Z96QXD6UM) |
LOOKING FOR A SUPPLIER?