SPL Set ID: e7b88a48-12b3-461d-b356-0d7ae4e8fd44
1 drug(s) with this SPL Set ID
Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4S-(4α,4aα,5aα,12aα)]-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below: Minocycline hydrochloride extended-release tablets USP for oral administration contain minocycline hydrochloride, USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, titanium dioxide, and triacetin. The 45 mg extended-release tablets also contain iron oxide black. The 55 mg extended-release tablets also contain FD&C Red # 40/Allura Red AC aluminum lake and polyethylene glycol. The 65 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake, FD&C Blue #2/Indigo caramine aluminum lake, and polyethylene glycol. The 80 mg extended-release tablets also contain FD&C Blue #2 indigo caramine aluminum lake, FD&C Red # 40/Allura Red AC aluminum lake, FD&C Yellow #6/Sunset yellow FCF aluminum lake and polyethylene glycol. The 90 mg extended-release tablets also contain iron oxide yellow and polyethylene glycol. The 105 mg extended-release tablets also contain D&C Red #27/Phloxine aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and polyethylene glycol. The 115 mg extended-release tablets also contain D&C Yellow #10 aluminum lake, FD&C Blue #1/Brilliant blue FCF aluminum lake and FD&C Blue #2/Indigo caramine aluminum lake. The 135 mg extended-release tablets also contain iron oxide red and polyethylene glycol. Meets USP dissolution test 2 for 45 mg, 90 mg and 135 mg. FDA approved dissolution test specifications differ from USP for 55 mg, 65 mg, 80 mg, 105 mg and 115 mg. Chemical Structure