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USFDA APPLICATION NUMBER - 21121 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 54MG
| 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) |
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