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USFDA APPLICATION NUMBER - 205831 / DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49) | METHYLPHENIDATE HYDROCHLORIDE | 10mg | 15mg | 20mg | 30mg | 40mg | 50mg | 60mg |
Inactive Ingredients
| Ingredient Name | Mayne Pharma | Granules Pharmaceuticals Inc. | American Health Packaging | Rhodes Pharmaceuticals L.P. | CorePharma, LLC | Kremers Urban Pharmaceuticals Inc. | Mckesson Rxpak Inc | Unither Manufacturing, LLC |
|---|---|---|---|---|---|---|---|---|
| ACETONE(1364PS73AF) | ||||||||
| ACETYLTRIBUTYL CITRATE(0ZBX0N59RZ) | ||||||||
| ALUMINUM OXIDE(LMI26O6933) | ||||||||
| AMMONIA(5138Q19F1X) | ||||||||
| AMMONIO METHACRYLATE COPOLYMER TYPE B(161H3B14U2) | ||||||||
| CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)(BEI30UXK2N) | ||||||||
| CELLULOSE ACETATE(3J2P07GVB6) | ||||||||
| CETYL ALCOHOL(936JST6JCN) | ||||||||
| D&C RED NO. 28(767IP0Y5NH) | ||||||||
| D&C RED NO. 33(9DBA0SBB0L) | ||||||||
| D&C YELLOW NO. 10(35SW5USQ3G) | ||||||||
| dibutyl sebacate(4W5IH7FLNY) | ||||||||
| ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B) | ||||||||
| ETHYLCELLULOSES(7Z8S9VYZ4B) | ||||||||
| FD&C BLUE NO. 1(H3R47K3TBD) | ||||||||
| FD&C BLUE NO. 2(L06K8R7DQK) | ||||||||
| FD&C GREEN NO. 3(3P3ONR6O1S) | ||||||||
| FD&C RED NO. 3(PN2ZH5LOQY) | ||||||||
| FD&C RED NO. 40(WZB9127XOA) | ||||||||
| FD&C YELLOW NO. 5(I753WB2F1M) | ||||||||
| FD&C YELLOW NO. 6(H77VEI93A8) | ||||||||
| FERRIC OXIDE RED(1K09F3G675) | ||||||||
| FERRIC OXIDE YELLOW(EX438O2MRT) | ||||||||
| FERROSOFERRIC OXIDE(XM0M87F357) | ||||||||
| GELATIN(2G86QN327L) | ||||||||
| GELATIN, UNSPECIFIED(2G86QN327L) | ||||||||
| HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(6N003M473W) | ||||||||
| HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(36BGF0E889) | ||||||||
| HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO) | ||||||||
| HYPROMELLOSES(3NXW29V3WO) | ||||||||
| METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J) | ||||||||
| POLYETHYLENE GLYCOL(3WJQ0SDW1A) | ||||||||
| POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A) | ||||||||
| POTASSIUM HYDROXIDE(WZH3C48M4T) | ||||||||
| POVIDONE(FZ989GH94E) | ||||||||
| POVIDONE, UNSPECIFIED(FZ989GH94E) | ||||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||||
| SHELLAC(46N107B71O) | ||||||||
| SHELLAC(MB5IUD6JUA) | ||||||||
| SILICON DIOXIDE(ETJ7Z6XBU4) | ||||||||
| SODIUM LAURYL SULFATE(368GB5141J) | ||||||||
| STARCH, CORN(O8232NY3SJ) | ||||||||
| SUCROSE(C151H8M554) | ||||||||
| TALC(7SEV7J4R1U) | ||||||||
| TITANIUM DIOXIDE(15FIX9V2JP) | ||||||||
| TRIETHYL CITRATE(8Z96QXD6UM) | ||||||||
| WATER(059QF0KO0R) |
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